Identity
- Trade Name
- RP UCLA Abutment Plastic, Hexed FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- The UCLA-Type Abutment is attached directly to the implant. It provides a pattern for the creation of a screw retained veneered crown. Sterngold UCLA 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. They are available in wrought titanium 6 AL-4V ELI, gold and Delrin plastic. FDA UDI
- Model / Reference
- 904139 FDA UDI
- Description
- The UCLA-Type Abutment is attached directly to the implant. It provides a pattern for the creation of a screw retained veneered crown. Sterngold UCLA 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. They are available in wrought titanium 6 AL-4V ELI, gold and Delrin plastic. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549110450 FDA UDI
- 510(k) Number
- K933193 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
RP UCLA Abutment Plastic, Hexed by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K933193 also covers:
- NP UCLA Abutment Waxing Sleeve, Hexed — Sterngold Dental LLC
- RP UCLA Abutment Gold, Hexed — Sterngold Dental LLC
- RP UCLA Abutment Gold, Non-Hexed — Sterngold Dental LLC
- RP UCLA Abutment Waxing Sleeve, Non-Hexed — Sterngold Dental LLC
- WP UCLA Abutment Gold, Hexed — Sterngold Dental LLC
- WP UCLA Abutment Gold, Non-Hexed — Sterngold Dental LLC
- WP UCLA Abutment Waxing Sleeve, Hexed — Sterngold Dental LLC
- WP UCLA Abutment Waxing Sleeve, Non-Hexed — 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 50830f93-cfde-41f9-b704-0b830a59a63e 36 fields · synced Jun 6, 2026