FDA Registration Active 🇺🇸 United States

Inclusive Tapered Implant Titanium Abutment, 3.5mmP x 4.5mmH

Reg #: 3011649314 · FEI: 3011649314 · Expires 2025
Products
1
Proprietary Names
127
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
K121406

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
Implant, Endosseous, Root-Form DZE

Proprietary Names

Inclusive Tapered Implant Titanium Abutment, 3.5mmP x 4.5mmH Surgical Drill 2.8/2.3 Short Open-Tray Transfer 4.5 x 4.5 x 10 Closed-Tray Transfer 4.5 x 5.7 x 8 UCLA Plastic Platform (Engaging) Inclusive Esthetic Abutment, Anterior, Straight, 3.5 Platform Inclusive Tapered Implant Titanium Esthetic Abutment, Anterior, 3.5 mmP x 1.5 mmH Scanning Abutment 3.5 Posterior Screw Tap 5.2 Inclusive Tapered Implant 5.2 x 10 mm Inclusive Temporary Abutment Engaging 3.5 Inclusive Healing Abutment 4.5 x 5.7 x 5 mm UCLA Plastic 4.5 Platform (Engaging) Inclusive Tapered Implant Titanium Esthetic Abutment, Anterior, 4.5mmP x 1.5mmH Inclusive Tapered Implant Titanium Abutment, 3.5mmP x 3mmH Inclusive Multi-Unit Scan, Abutment Multi-Unit Impression Coping Open Cortical Bone Drill 1.7 Inclusive Healing Abutment 3.5 x 4.7 x 3 mm Implant Analog 3.5 Inclusive Temporary Abutment Non-Engaging 3.5 Inclusive Tapered Implant 4.7 x 10 mm Inclusive Tapered Implant Healing Abutment 3.5 mmP x 4.7 mmD x 7 mmH Temporary Abutment 3.5mm Non-engaging Parallel Pin Inclusive Prosthetic Screw SCS Multi-Unit Plastic Coping Multi-Unit Abutment 4.5 Platform x 3mmH Handpiece Hex Driver (long) Inclusive Tapered Implant 4.7 x 8 mm Temporary Abutment 4.5mm Engaging Lab Screw, 1-72 Implant Driver (long) Inclusive Tapered Implant 5.2 x 8 mm Inclusive Healing Abutment 4.5 x 5.7 x 3 mm Inclusive Healing Abutment 4.5 x 4.5 x 3 mm Inclusive Tapered Implant Healing Abutment 3.5 mmP x 3.5 mmD x 7 mmH Inclusive Esthetic Abutment, Posterior, 15 Degree Angle, 4.5 Platform 4.5 Posterior Straight Esthetic Abutment Inclusive Esthetic Abutment, Anterior, 15 Degree Angle, 3.5 Platform Inclusive Tapered Implant 15 deg Titanium Esthetic Abutment, Anterior, 3.5 mmP x 1.5 mmH Inclusive Tapered Implant 5.2 x 13 mm Multi-Unit Abutment 4.5 Platform x 5mmH Multi-Unit Abutment 4.5 Platform x 1mmH Abutment Screw Surgical Drill 3.8/3.4 Long Inclusive Tapered Implant 15 Deg Titanium Esthetic Abutment, Anterior, 4.5mmP x 1.5mmH Inclusive Lab Screw 1-72 5/pk Inclusive Prosthetic Screw Closed-Tray Transfer 4.5 x 4.5 x 8 Inclusive Tapered Implant Healing Abutment 4.5 mmP x 4.5 mmD x 7 mmH Inclusive Tapered Implant Titanium Abutment, 4.5mmP x 3mmH Inclusive Tapered Implant 5.2 x 16 mm Inclusive Tapered Implant Titanium Abutment 3.5 mmP x 6 mmH Closed-Tray Tranfer 3.5 x 3.5 x 8 Inclusive Tapered Implant 4.7 x 11.5 mm Handpiece Hex Driver (short) Inclusive Healing Abutment 3.5 x 3.5 x 5 mm Surgical Drill 4.4/3.8 Short Multi-Unit Prosthetic Screw Surgical Drill 3.8/3.4 Short Inclusive Healing Abutment 3.5 x 4.7 x 5 mm Inclusive Prosthetic Screw 1 mm Hex Inclusive Titanium Abutment, 4.5 Platform, 6 mmH Drill Extender Inclusive Esthetic Abutment, Posterior, Straight, 4.5 Platform Inclsuive Titanium Abutment, 4.5 Platform, 6 mmH Inclusive Tapered Implant 3.7 x 16 mm Inclusive Tapered Implant 5.2 x 11.5 mm Inclusive Temporary Abutment Non-Engaging 4.5 Inclusive Tapered Implant Healing Abutment 4.5 mmP x 5.7 mmD x 7 mmH Inclusive Abutment Screw Inclusive Prosthetic Screw 48 Hex Inclusive Tapered Implant 3.7 x 11.5 mm 3.5 Anterior Straight Esthetic Abutment Inclusive Abutment Screw 5/pk Inclusive Tapered Implant 4.7 x 13 mm Surgical Drill 3.4/2.8 Short Multi-Unit Temporary Abutment 3.5 Multi-Unit Gold Plastic Bar Coping 3mm Abutment 3.5mm x 3mm Inclusive Tapered Implant Titanium Esthetic Abutment, Anterior, 4.5mmP x 3mmH Inclusive Healing Abutment 4.5 x 4.5 x 5 mm Inclusive Angled Multi-Unit Abutment Screw Inclusive Tapered Implant Titanium Abutment 4.5 mmP x 6 mmH Temporary Abutment 4.5mm Non-engaging Inclusive Tapered Implant Titanium Screw UCLA Plastic 4.5 Platform (Non-engaging) Inclusive Temporary Abutment Engaging 4.5 Lance Drill Open-Tray Transfer 3.5 x 4.7 x 10 Inclusive® Tapered Implant 4.2 mmD x 11.5 mmL x 3.5 mmP Inclusive Tapered Implant 3.7 x 10 mm Handpiece Implant Driver (short) Inclusive Esthetic Abutment, Posterior, Straight, Wide, 4.5 Platform Multi-Unit Abutment Analog Open-Tray Impression Screw Screw Tap 3.7 Inclusive Tapered Implant 15 Deg Titanium Esthetic Abutment, Anterior, 4.5mmP x 3mmH Inclusive Healing Abutment 3.5 x 3.5 x 3 mm Surgical Instrument Tray Complete Closed-Tray Impression Screw Radiographic Template Multi-Unit Temporary Abutment with Guide Pin Inclusive Tapered Implant Titanium Abutment 4.5mmP X 4.5 mmH Inclusive Tapered Implant 3.7 x 8 mm Inclusive Abutment Blank 3.5 Multi-Unit Abutment 3.5 Platform x 1mmH Inclusive Titanium Abutment, 3.5 Platform, 6 mmH Handpiece Implant Driver (long) Inclusive Abutment Blank 4.5 Pilot Drill 2.3/2 Short Cover Screw 4.5 Inclusive Tapered Implant 3.7 x 13 mm Surgical Bone Drill 2.8/2.3Long Inclusive Tapered Implant GL Titanium Abutment 3.5 mmP x 6 mmH Inclusive Tapered Implant 4.7 x 16 mm UCLA Gold Abutment 4.5 Platform Engaging Inclusive Multi-Unit Prosthetic Screw 50 Hex Surgical Drill 3.4/2.8 Long Inclusive Tapered Implant GL Titanium Abutment 4.5 mmP x 4.5 mmH Inclusive Tapered Implant GL Titanium Abutment 4.5 mmP x 6 mmH Inclusive Tapered Implant GL Titanium Abutment 3.5 mmP x 4.5 mmH Inclusive® Tapered Implant 4.2 mmD x 10 mmL x 3.5 mmP Inclusive® Tapered Implant 4.2 mmD x 13 mmL x 3.5 mmP Inclusive® Tapered Implant 4.2 mmD x 16 mmL x 3.5 mmP Inclusive® Tapered Implant 4.2 mmD x 8 mmL x 3.5 mmP

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device