FDA Registration Active 🇺🇸 United States

Inclusive 30 degree Multi-Unit Abutment 4 mmH compatible with: Biomet 3i Certain 4.1 mm

Reg #: 3011649314 · FEI: 3011649314 · Expires 2025
Products
1
Proprietary Names
191
Establishment Types
2
Classifications
1

Registration Details

Registration Name
PRISMATIK DENTALCRAFT, INC.
Registration Number
3011649314
FEI Number
3011649314
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
2144 Michelson Drive
City
Irvine
State
CA
ZIP
92612
Country
US

Regulatory Submissions

510(k) Number
K121688

Owner / Operator

Firm Name
PRISMATIK DENTALCRAFT, INC.
Operator Number
10043585
Address
2144 Michelson Drive
City
Irvine
State
CA
Postal Code
92612
Country
US
Correspondent
Michelle Gallup

Products

Device Name Product Code
Abutment, Implant, Dental, Endosseous NHA

Proprietary Names

Inclusive 30 degree Multi-Unit Abutment 4 mmH compatible with: Biomet 3i Certain 4.1 mm Inclusive 30 degree Multi-Unit Abutment 4.5 mmH compatible with: Dentsply Implants Ankylos C/X 3.5/4.5/5.5/7 mm Inclusive Multi-Unit Abutment 3 mmH compatible with: Nobel Biocare Branemark System RP Inclusive Multi-Unit Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 4.5/5 Inclusive Multi-Unit Abutment 2.5 mmH compatible with: Straumann Bone Level RC Inclusive Multi-Unit Abutment 3 mmH compatible with: Biomet 3i Certain 5 mm Inclusive Tapered Implant 17 Degree Multi-Unit Abutment, 4.5 Platform x 3 mmH Inclusive 30degree Multi-Unit Abut. 5.5 mmH compatible with: MegaGen AnyRidge Implant System Inclusive 30 degree Multi-Unit Abutment 3.5 mmH compatible with: Nobel Biocare NobelActive NP Inclusive Tapered Implant 30degree Multi-Unit Abut. 3.5 mmP x 3 mmH Inclusive Angled Multi-Unit Abutment Screw Inclusive Multi-Unit Abut. 2 mmH compatible with: MegaGen AnyrRdge Implant System Inclusive 17 Degree Multi-Unit Abutment, 3 mmH for CAMLOG SCREW-LINE 4.3 mm Inclusive 17 degree Multi-Unit Abutment 2 mmH compatible with: Biomet 3i Certain 5 mm Inclusive 17degree Multi-Unit Abut. 5.5 mmH compatible with: MegaGen AnyRidge Implant System Inclusive 17 degree Multi-Unit Abutment 2 mmH compatible with: Biomet 3i Certain 4.1 mm Inclusive Multi-Unit Abutment 1 mmH compatible with: Biomet 3i Certain 4.1 mm Inclusive Tapered Implant Multi-Unit Abutment, 3.5 Platform x 2 mmH Inclusive Multi-Unit Abutment 3 mmH compatible with: Biomet 3i Certain 3.4 mm Inclusvie 17 degree Multi-Unit Abutment 2 mmH compatible with: Nobel Biocare NobelReplace WP Inclusive Tapered Implant 17 Degree Multi-Unit Abutment, 4.5 Platform x 5 mmH Inclusive Tapered Implant 17degree Multi-Unit Abut. 3.5 mmP x 3 mmH Inclusive 17 degree Multi-Unit Abutment 3.5 mmH compatible with: Nobel Biocare NobelActive RP Inclusive 17degree Multi-Unit Abut. 2.5 mmH compatible with: Hiossen HG System Standard Iinclusive 30 Degree Multi-Unit Abutment, 3 mmH for CAMLOG SCREW-LINE 3.8 mm Inclusive Multi-Unit Abutment 3.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 4.5/5 Inclusive Angled Multi-Unit Abutment Screw compatible with: Dentsply Implants Astra Tech Implant System 3.5/4 Inclusive 17 Degree Multi-Unit Abutment, 2 mmH for CAMLOG SCREW-LINE 3.8 mm Inclusive Multi-Unit Abutment 3 mmH for CAMLOG SCREW-LINE 5 mm Inclusive Multi-Unit Abutment 5 mmH compatible with: MegaGen AnyRidge Implant System Inclusive Angled Multi-Unit Abutment Screw compatible with: Nobel Biocare NobelReplace NP Inclusive Multi-Unit Abutment 1 mmH for CAMLOG SCREW-LINE 4.3 mm Inclusive Multi-Unit Abutment 2 mmH compatible with: Biomet 3i Certain 3.4 mm Inclusive Angled Multi-Unit Abutment Screw compatible with: Camlog Screw-Line 3.8/4.3 mm Inclusive Multi-Unit Abutment 2 mmH for CAMLOG SCREW-LINE 3.8 mm Inclusive Tapered Implant 17degree Multi-Unit Abut. 4.5 mmP x 5 mmH Inclusive 17degree Multi-Unit Abut. 4.5 mmH compatible with: MegaGen AnyRidge Implant System Inclusive Multi-Unit Prosthetic Screw 48" Hex Inclusive Multi-Unit Abutment 2.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 4.5/5 Inclusive 30 Degree Multi-Unit Abutment, 5 mmH for CAMLOG SCREW-LINE 3.8 mm Inclusive 17 degree Multi-Unit Abutment 2.5 mmH compatible with: Straumann Bone Level NC Inclusive Multi-Unit Abutment 4.5 mmH compatible with: Dentsply Implants Ankylos C/X 3.5/4.5/5.5/7 mm Inclusive Multi-Unit Abutment 2.5 mmH compatible with: Straumann Bone Level NC Inclusive Angled Multi-Unit Abutment Screw compatible with: Nobel Biocare NobelActive RP Inclusive Multi-Unit Abutment 1 mmH for CAMLOG SCREW-LINE 5 mm Inclusive Tapered Implant Multi-Unit Abutment, 4.5 Platform x 2 mmH Inclusive Multi-Unit Abutment 1.5 mmH compatible with: Hiossen HG System Standard Inclusive 17 Degree Multi-Unit Abutment, 2 mmH for CAMLOG SCREW-LINE 4.3 mm Inclusive Tapered Implant 17degree Multi-Unit Abut. 3.5 mmP x 2 mmH Inclusive 17 degree Multi-Unit Abutment 3 mmH compatible with: Biomet 3i Certain 4.1 mm Inclusive Multi-Unit Abutment 2.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 3.5/4 Inclusive 17 degree Multi-Unit Abutment 3.5 mmH compatible with: Dentsply Implants Ankylos C/X 3.5/4.5/5.5/7 mm Inclusive 30degree Multi-Unit Abut. 4.5 mmH compatible with: Hiossen HG System Mini Inclusive 17 degree Multi-Unit Abutment 3.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 4.5/5 Inclusive 17 degree Multi-Unit Abutment 3 mmH compatible with: Nobel Biocare NobelReplace NP Inclusive Tapered Implant 30 Degree Multi-Unit Abutment, 3.5 Platform x 3 mmH Inclusive 17 degree Multi-Unit Abutment 3 mmH compatible with: Nobel Biocare NobelReplace WP Inclusive Multi-Unit Abutment 2.5 mmH compatible with: Hiossen HG System Standard Inclusive 30 degree Multi-Unit Abutment 5 mmH compatible with: Nobel Biocare NobelReplace RP Inclusive Tapered Implant Multi-Unit Abutment, 4.5 Platform x 5 mmH Inclusive Multi-Unit Abutment. 4 mmH compatible with: MegaGen AnyRidge Implant System Inclusive 17 degree Multi-Unit Abutment 2.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 4.5/5 Inclusive Multi-Unit Abut. 5 mmH compatible with: MegaGen AnyRidge Implant System Inclusive 30 degree Multi-Unit Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 4.5/5 Inclusive Multi-Unit Abutment 2 mmH for CAMLOG SCREW-LINE 5 mm Inclusive Multi-Unit Abutment 3.5 mmH compatible with: Straumann Bone Level NC Inclusive 30degree Multi-Unit Abut. 3.5 mmH compatible with: MegaGen AnyRidge Implant System Inclusive Multi-Unit Abutment 3 mmH compatible with: Nobel Biocare NobelReplace WP Inclusive Multi-Unit Abutment 3.5 mmH compatible with: Straumann Bone Level RC Inclusive 17 degree Multi-Unit Abutment 3.5 mmH compatible with: Straumann Bone Level RC Inclusive Multi-Unit Abutment 2 mmH compatible with: MegaGen AnyRidge Implant System Inclusive 17 degree Multi-Unit Abutment 2.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 3.5/4 Inclusive Multi-Unit Abutment 3 mmH for CAMLOG SCREW-LINE 3.8 mm Inclusive Tapered Implant 17 Degree Multi-Unit Abutment, 4.5 Platform x 2 mmH Inclusive 30 degree Multi-Unit Abutment 4.5 mmH compatible with: Nobel Biocare NobelActive NP Inclusive 30 degree Multi-Unit Abutment 4 mmH compatible with: Nobel Biocare NobelReplace RP Inclusive Tapered Implant Multi-Unit Abutment, 4.5 Platform x 1 mmH Inclusive 17 degree Multi-Unit Abutment 2.5 mmH compatible with: Dentsply Implants Ankylos C/X 3.5/4.5/5.5/7 mm Inclusive 30degree Multi-Unit Abut. 3.5 mmH compatible with: Hiossen HG System Standard Inclusive 30degree Multi-Unit Abut. 4.5 mmH compatible with: MegaGen AnyRidge Implant System Inclusive Multi-Unit Abutment 2.5 mmH compatible with: Dentsply Implants Ankylos C/X 3.5/4.5/5.5/7 mm Inclusive 17 degree Multi-Unit Abutment 3 mmH compatible with: Nobel Biocare NobelReplace RP Inclusive Multi-Unit Abutment 4.5 mmH compatible with: Hiossen HG System Standard Inclusive Multi-Unit Abutment 2.5 mmH compatible with: Hiossen HG System Mini Inclusive Tapered Implant 17degree Multi-Unit Abut. 4.5 mmP x 2 mmH Inclusive Angled Multi-Unit Abutment Screw compatible with: Nobel Biocare NobelActive NP Inclusive 17 degree Multi-Unit Abutment 3.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 3.5/4 Incuisive 17 degree Multi-Unit Abutment 2 mmH compatible with: Nobel Biocare NobelReplace RP Inclusive Multi-Unit Prosthetic Screw SCS Inclusive Multi-Unit Abutment 3 mmH compatible with: Nobel Biocare NobelReplace RP Inclusive Tapered Implant 30 Degree Multi-Unit Abutment, 4.5 Platform x 3 mmH Inclusive 30 degree Multi-Unit Abutment 3.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 4.5/5 Inclusvie 17 degree Multi-Unit Abutment 2 mmH compatible with: Nobel Biocare NobelReplace NP Inclusive 17degree Multi-Unit Abut. 3.5 mmH compatible with: MegaGen AnyRidge Implant System Inclusive Multi-Unit Abutment 3.5 mmH compatible with: Nobel Biocare NobelActive NP Inclusive Tapered Implant 30degree Multi-Unit Abut. 4.5 mmP x 3 mmH Inclusive Multi-Unit Abutment 3 mmH compatible with: Nobel Biocare NobelReplace NP Inclusive 30degree Multi-Unit Abut. 3.5 mmH compatible with: Hiossen HG System Mini Inclusive 17 degree Multi-Unit Abutment 3 mmH compatible with: Nobel Biocare Branemark System RP Inclusive Multi-Unit Abutment 1 mmH compatible with: Straumann Tissue Level RN synOcta Inclusive Multi-Unit Titanium Temporary with Prosthetic Screw 50 Hex Inclusive Angled Multi-Unit Abutment Screw compatible with: Nobel Biocare Branemark RP Inclusive 30 degree Multi-Unit Abutment 5 mmH compatible with: Biomet 3i Certain 4.1 mm Inclusive Tapered Implant 17 Degree Multi-Unit Abutment, 3.5 Platform x 2 mmH Inclusive 17 Degree Multi-Unit Abutment, 5 mmH for CAMLOG SCREW-LINE 4.3 mm Inclusive Multi-Unit Abutment 1.5 mmH compatible with: Nobel Biocare NobelActive RP Inclusive 17 degree Multi-Unit Abutment 2.5 mmH compatible with: Nobel Biocare NobelActive RP Inclusive Multi-Unit Abutment 5 mmH compatible with: Biomet 3i Certain 4.1 mm Inclusive 30 degree Multi-Unit Abutment 3.5 mmH compatible with: Straumann Bone Level RC Inclusive Tapered Implant 17 Degree Multi-Unit Abutment, 3.5 Platform x 3 mmH Inclusive 17 degree Multi-Unit Abutment 3.5 mmH compatible with: Straumann Bone Level NC Inclusive Tapered Implant 17degree Multi-Unit Abut. 4.5 mmP x 3 mmH Inclusive Multi-Unit Abutment 1 mmH compatible with: Nobel Biocare Branemark System RP Inclusive 17 degree Multi-Unit Abutment 2.5 mmH compatible with: Nobel Biocare NobelActive NP Inclusive Multi-Unit Temporary Healing Cap with Prosthetic Screw 50 Hex Inclusive Multi-Unit Abutment 5 mmH compatible with: Nobel Biocare Branemark System RP Inclusive Multi-Unit Abutment 3.5 mmH compatible with: Hiossen HG System Standard Inclusive Multi-Unit Abutment 1.5 mmH compatible with: Hiossen HG System Mini Inclusive 17 degree Multi-Unit Abutment 2.5 mmH compatible with: Straumann Bone Level RC Inclusive 17 degree Multi-Unit Abutment 4 mmH compatible with: Nobel Biocare NobelReplace RP Inclusive 17 degree Multi-Unit Abutment 3.5 mmH compatible with: Nobel Biocare NobelActive NP Inclusive 30 degree Multi-Unit Abutment 3.5 mmH compatible with: Dentsply Implants Ankylos C/X 3.5/4.5/5.5/7 mm Inclusive Multi-Unit Abutment 1.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 3.5/4 Inclusive Angled Multi-Unit Abutment Screw compatible with: Biomet 3i Certain 3.4/4.1/5/6 mm Inclusive Multi-Unit Abut. 4 mmH compatible with: MegaGen AnyRidge Implant System Inclusive Multi-Unit Abutment 5 mmH for CAMLOG SCREW-LINE 4.3 mm Inclusive 17degree Multi-Unit Abut. 2.5 mmH compatible with: Hiossen HG System Mini Inclusive Multi-Unit Abutment 5 mmH compatible with: Nobel Biocare NobelReplace RP Inclusive Multi-Unit Abutment 1 mmH compatible with: Nobel Biocare NobelReplace NP Inclusive 30 degree Multi-Unit Abutment 3.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 3.5/4 Inclusive Tapered Implant Multi-Unit Abutment, 3.5 Platform x 1 mmH Inclusive 30 degree Multi-Unit Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 3.5/4 Inclusive Tapered Implant 30 Degree Multi-Unit Abutment, 4.5 Platform x 5 mmH Inclusive Multi-Unit Abutment 1 mmH compatible with: Nobel Biocare NobelReplace RP Inclusive 17 degree Multi-Unit Abutment 3 mmH compatible with: Biomet 3i Certain 3.4 mm Inclusive Multi-Unit Abutment 1.5 mmH compatible with: Dentsply Implants Ankylos C/X 3.5/4.5/5.5/7 mm Inclusive Multi-Unit Abutment 1.5 mmH compatible with: Straumann Bone Level RC Inclusive Multi-Unit Abutment 1.5 mmH compatible with: Nobel Biocare NobelActive NP Inclusive Multi-Unit Abutment 3.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 3.5/4 Inclusive Angled Multi-Unit Abutment Screw compatible with: Straumann Bone Level NC/RC Inclusive Multi-Unit Abutment 2 mmH for CAMLOG SCREW-LINE 4.3 mm Inclusive Multi-Unit Abutment 2.5 mmH compatible with: Nobel Biocare NobelActive RP Inclusive Multi-Unit Abutment 4.5 mmH compatible with: Nobel Biocare NobelActive RP Inclusive Multi-Unit Abutment 3.5 mmH compatible with: Hiossen HG System Mini Inclusive Tapered Implant Multi-Unit Abutment 3.5 mmP x 5 mmH Inclusive 17 degree Multi-Unit Abutment 4 mmH compatible with: Nobel Biocare Branemark System RP Inclusive 30degree Multi-Unit Abut. 6.5 mmH compatible with: MegaGen AnyRidge Implant System Inclusive 30 degree Multi-Unit Abutment 4 mmH compatible with: Nobel Biocare Branemark System RP Inclusive Multi-Unit Abutment 3 mmH for CAMLOG SCREW-LINE 4.3 mm Inclusive Angled Multi-Unit Abutment Screw compatible with: Nobel Biocare NobelReplace RP Inclusive Multi-Unit Abutment 1.5 mmH compatible with: Dentsply Implants Astra Tech Implant System 4.5/5 Inclusive Multi-Unit Abutment 1 mmH compatible with: Biomet 3i Certain 3.4 mm Inclusive Multi-Unit Abutment 2 mmH compatible with: Biomet 3i Certain 4.1 mm Inclusive 17 degree Multi-Unit Abutment 2 mmH compatible with: Nobel Biocare Branemark System RP Inclusive Multi-Unit Abutment 2 mmH compatible with: Nobel Biocare NobelReplace RP Inclusive Multi-Unit Abut. 3 mmH compatible with: MegaGen AnyRidge Implant System Inclusive Multi-Unit Abutment 4.5 mmH compatible with: Straumann Bone Level RC Inclusive Multi-Unit Abutment 1.5 mmH compatible with: Straumann Tissue Level WN synOcta Inclusive 17degree Multi-Unit Abut. 3.5 mmH compatible with: Hiossen HG System Standard Inclusive 17 degree Multi-Unit Abutment 2 mmH compatible with: Biomet 3i Certain 3.4 mm Inclusive 30 degree Multi-Unit Abutment 4.5 mmH compatible with: Nobel Biocare NobelActive RP Inclusive Tapered Implant Multi-Unit Abutment, 4.5 Platform x 3 mmH Inclusive 30 degree Multi-Unit Abutment 4.5 mmH compatible with: Straumann Bone Level RC Inclusive 30 degree Multi-Unit Abutment 5 mmH compatible with: Nobel Biocare Branemark System RP Inclusive 30 Degree Multi-Unit Abutment, 5 mmH for CAMLOG SCREW-LINE 4.3 mm Inclusive Multi-Unit Abutment 3.5 mmH compatible with: Dentsply Implants Ankylos C/X 3.5/4.5/5.5/7 mm Inclusive Multi-Unit Abutment 2 mmH compatible with: Nobel Biocare NobelReplace WP Inclusive Multi-Unit Abutment 3 mmH compatible with: MegaGen AnyRidge Implant System Inclusive Multi-Unit Abutment 1 mmH compatible with: Nobel Biocare NobelReplace WP Inclusive 17 Degree Multi-Unit Abutment, 3 mmH for CAMLOG SCREW-LINE 3.8 mm Inclusive Multi-Unit Abutment 2.5 mmH compatible with: Nobel Biocare NobelActive NP Inclusive Multi-Unit Temporary Healing Cap Inclusive Tapered Implant Multi-Unit Abutment 3.5 mmP x 3 mmH Inclusive Multi-Unit Abutment 1 mmH for CAMLOG SCREW-LINE 3.8 mm Inclusive 17degree Multi-Unit Abut. 3.5 mmH compatible with: Hiossen HG System Mini Inclusive Tapered Implant 30degree Multi-Unit Abut. 4.5 mmP x 5 mmH Inclusive Multi-Unit Abutment 3 mmH compatible with: Biomet 3i Certain 4.1 mm Inclusive 17 degree Multi-Unit Abutment 3 mmH compatible with: Biomet 3i Certain 5 mm Inclusive 30 degree Multi-Unit Abutment 3.5 mmH compatible with: Nobel Biocare NobelActive RP Inclusive Multi-Unit Abutment Screw Inclusive Angled Multi-Unit Abutment Screw compatible with: Dentsply Implant Ankylos C/X Inclusive Angled Multi-Unit Abutment Screw compatible with: Dentsply Implants Astra Tech Implant System 4.5/5 Inclusive Multi-Unit Abutment 3.5 mmH compatible with: Nobel Biocare NobelActive RP Inclusive Multi-Unit Abutment 2 mmH compatible with: Nobel Biocare Branemark System RP Inclusive Multi-Unit Prosthetic Screw 50" Hex Inclusive Multi-Unit Abutment 2 mmH compatible with: Biomet 3i Certain 5 mm Inclusive 30degree Multi-Unit Abut. 4.5 mmH compatible with: Hiossen HG System Standard Inclusive 30 Degree Multi-Unit Abutment, 3 mmH for CAMLOG SCREW-LINE 4.3 mm Inclusive Multi-Unit Abutment 2 mmH compatible with: Nobel Biocare NobelReplace NP Inclusive Multi-Unit Abutment 1.5 mmH compatible with: Straumann Bone Level NC Inclusive Multi-Unit Abutment 1 mmH compatible with: Biomet 3i Certain 5 mm

Establishment Types

Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198