FDA Registration
Active
🇺🇸 United States
Inclusive® Titanium Abutment Blank c/w: Dentsply Implants Astra Tech Implant System® EV 4.2
Reg #: 3011649314
·
FEI: 3011649314
·
Expires 2025
Products
1
Proprietary Names
53
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
- K191222
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 |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2019-08-20 |
Proprietary Names
Inclusive® Titanium Abutment Blank c/w: Dentsply Implants Astra Tech Implant System® EV 4.2
Inclusive® Titanium Abutment 4.5 mmH c/w: Dentsply Implants Astra Tech Implant System® EV 4.2
Inclusive® Titanium Esthetic Abutment, Anterior, c/w: Dentsply Implants Astra Tech Implant System® EV 4.2
Inclusive® 15 degree Titanium Esthetic Abutment, Posterior, c/w: Dentsply Implants Astra Tech Implant System® EV 4.2
Inclusive® Titanium Abutment 4.5 mmH c/w: Dentsply Implants Astra Tech Implant System® EV 3
Inclusive® Titanium Screw c/w: Dentsply Implants Astra Tech Implant System® EV 4.2
Inclusive® Titanium Screw c/w: Dentsply Implants Astra Tech Implant System® EV 5.4
Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, c/w: Dentsply Implants Astra Tech Implant System® EV 5.4
Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, c/w: Dentsply Implants Astra Tech Implant System® EV 4.8
Inclusive® 15 degree Titanium Esthetic Abutment, Anterior, c/w: Dentsply Implants Astra Tech Implant System® EV 3
Inclusive® 15 degree Titanium Esthetic Abutment, Anterior, c/w: Dentsply Implants Astra Tech Implant System® EV 4.8
Inclusive® Titanium Esthetic Abutment, Posterior, c/w: Dentsply Implants Astra Tech Implant System® EV 4.2
Inclusive® Titanium Abutment 6 mmH c/w: Dentsply Implants Astra Tech Implant System® EV 4.2
Inclusive® Titanium Screw c/w: Dentsply Implants Astra Tech Implant System® EV 3
Inclusive® Titanium Esthetic Abutment, Anterior, c/w: Dentsply Implants Astra Tech Implant System® EV 5.4
Inclusive® Titanium Esthetic Abutment, Anterior, c/w: Dentsply Implants Astra Tech Implant System® EV 3.6
Inclusive GL Titanium Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System EV 4.8
Inclusive® Titanium Abutment 4.5 mmH c/w: Dentsply Implants Astra Tech Implant System® EV 5.4
Inclusive® Titanium Abutment 6 mmH c/w: Dentsply Implants Astra Tech Implant System® EV 3.6
Inclusive® 15 degree Titanium Esthetic Abutment, Posterior, c/w: DENTSPLY Implants ASTRA TECH Implant System® EV 3.6
Inclusive® Titanium Abutment Blank c/w: Dentsply Implants Astra Tech Implant System® EV 4.8
Inclusive® Titanium Screw c/w: Dentsply Implants Astra Tech Implant System® EV 4.8
Inclusive® Titanium Esthetic Abutment, Posterior, c/w: DENTSPLY Implants ASTRA TECH Implant System® EV 3.6
Inclusive® 15 degree Titanium Esthetic Abutment, Anterior, c/w: Dentsply Implants Astra Tech Implant System® EV 3.6
Inclusive® Titanium Abutment 4.5 mmH c/w: Dentsply Implants Astra Tech Implant System® EV 4.8
Inclusive® Titanium Abutment Blank c/w: Dentsply Implants Astra Tech Implant System® EV 5.4
Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, c/w: Dentsply Implants Astra Tech Implant System® EV 3
Inclusive® 15 degree Titanium Esthetic Abutment, Posterior, c/w: Dentsply Implants Astra Tech Implant System® EV 5.4
Inclusive® Titanium Abutment Blank c/w: Dentsply Implants Astra Tech Implant System® EV 3
Inclusive® Titanium Abutment Blank c/w: Dentsply Implants Astra Tech Implant System® EV 3.6
Inclusive GL Titanium Abutment 6 mmH compatible with: Dentsply Implants Astra Tech Implant System EV 4.2
Inclusive GL Titanium Abutment 6 mmH compatible with: Dentsply Implants Astra Tech Implant System EV 4.8
Inclusive® 15 degree Titanium Esthetic Abutment, Anterior, c/w: Dentsply Implants Astra Tech Implant System® EV 4.2
Inclusive® Titanium Esthetic Abutment, Anterior, c/w: Dentsply Implants Astra Tech Implant System® EV 4.8
Inclusive® Titanium Esthetic Abutment, Anterior, c/w: Dentsply Implants Astra Tech Implant System® EV 3
Inclusive® 15 degree Titanium Esthetic Abutment, Posterior, c/w: Dentsply Implants Astra Tech Implant System® EV 4.8
Inclusive® Titanium Screw c/w: Dentsply Implants Astra Tech Implant System® EV 3.6
Inclusive® Titanium Abutment 6 mmH c/w: Dentsply Implants Astra Tech Implant System® EV 4.8
Inclusive® 15 degree Titanium Esthetic Abutment, Anterior, c/w: Dentsply Implants Astra Tech Implant System® EV 5.4
Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, c/w: Dentsply Implants Astra Tech Implant System® EV 3.6
Inclusive® Titanium Abutment 6 mmH c/wh: Dentsply Implants Astra Tech Implant System® EV 5.4
Inclusive® Titanium Esthetic Abutment, Posterior, c/wh: Dentsply Implants Astra Tech Implant System® EV 4.8
Inclusive® Titanium Abutment 4.5 mmH c/w: Dentsply Implants Astra Tech Implant System® EV 3.6
Inclusive® Titanium Abutment 4.5 mmH, Non-Engaging, c/w: Dentsply Implants Astra Tech Implant System® EV 4.2
Inclusive GL Titanium Abutment 6 mmH compatible with: Dentsply Implants Astra Tech Implant System EV 5.4
Inclusive® Titanium Esthetic Abutment, Posterior, c/w: Dentsply Implants Astra Tech Implant System® EV 5.4
Inclusive® Titanium Abutment 6 mmH c/w: Dentsply Implants Astra Tech Implant System® EV 3
Inclusive GL Titanium Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System EV 3.6
Inclusive GL Titanium Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System EV 4.2
Inclusive GL Titanium Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System EV 5.4
Inclusive GL Titanium Abutment 6 mmH compatible with: Dentsply Implants Astra Tech Implant System EV 3.6
Inclusive GL Titanium Abutment 6 mmH compatible with: Dentsply Implants Astra Tech Implant System EV 3
Inclusive GL Titanium Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System EV 3
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device