Identity
- Trade Name
- PUR UCLA Abutment RP Non-Engaging - GOLD FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- PUR UCLA Abutment RP Non-Engaging Gold. The UCLA-Type Abutment is attached directly to the implant. It provides a pattern for the creation of a screw retained veneered crown. UCLA-Type Abutments are available in single-implant (hexed) and multi-implant (non-hexed) designs. This abutment is well suited for sites with minimal thickness of soft tissue. FDA UDI
- Model / Reference
- 904767 FDA UDI
- Description
- PUR UCLA Abutment RP Non-Engaging Gold. The UCLA-Type Abutment is attached directly to the implant. It provides a pattern for the creation of a screw retained veneered crown. UCLA-Type Abutments are available in single-implant (hexed) and multi-implant (non-hexed) designs. This abutment is well suited for sites with minimal thickness of soft tissue. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549113499 FDA UDI
- 510(k) Number
- K151928 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
PUR UCLA Abutment RP Non-Engaging - GOLD 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 |
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Manufacturer
- Manufacturer
- Sterngold Dental LLC
Sources (1)
- FDA UDI dae0f380-264f-420e-95b2-02ca15c87568 36 fields · synced Jun 8, 2026