Identity
- Trade Name
- PUR NP Cover Screw 4.3mm, Ti FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Component that is attached to implant to protect hex, mating surface area and internal threads of implants. A cover screw closes off the inside threads of a dental implant during the period of bone healing and implant integration. Healed gingival tissue covers the cover screw and implant. Available as an Internal Hex Cover Screw and on Regular and Narrow Platforms. FDA UDI
- Model / Reference
- 901377 FDA UDI
- Description
- Component that is attached to implant to protect hex, mating surface area and internal threads of implants. A cover screw closes off the inside threads of a dental implant during the period of bone healing and implant integration. Healed gingival tissue covers the cover screw and implant. Available as an Internal Hex Cover Screw and on Regular and Narrow Platforms. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549107597 FDA UDI
- 510(k) Number
- K151928 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
PUR NP Cover Screw 4.3mm, Ti by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K151928 also covers:
- PUR NP Implant 3.5 x 10mm, Ti — Sterngold Dental LLC
- PUR NP Implant 3.5 x 12mm, Ti — Sterngold Dental LLC
- PUR NP Implant 3.5 x 14mm, Ti — Sterngold Dental LLC
- PUR NP Implant 3.5 x 8mm, Ti — Sterngold Dental LLC
- PUR NP Implant 4.3 x 10mm, Ti — Sterngold Dental LLC
- PUR NP Implant 4.3 x 12mm, Ti — Sterngold Dental LLC
- PUR NP Implant 4.3 x 14mm, Ti — Sterngold Dental LLC
- PUR NP Implant 4.3 x 8mm, Ti — Sterngold Dental LLC
- PUR NP Implant 5.0 x 10mm, Ti — Sterngold Dental LLC
- PUR NP Implant 5.0 x 12mm, Ti — Sterngold Dental LLC
- PUR NP Implant 5.0 x 8mm, Ti — Sterngold Dental LLC
- PUR NP Implant 6.0 x 10mm, Ti — Sterngold Dental LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sterngold Dental LLC
Sources (1)
- FDA UDI 6dfe75a0-12cc-43a9-8bb0-f5ba9b74d750 36 fields · synced May 31, 2026