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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2013-03-15 |
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