Identity
- Trade Name
- NP UCLA Abutment Waxing Sleeve, 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
- 904516 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
- 00841549111778 FDA UDI
- 510(k) Number
- K933193 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- 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
Category: Dental implant suprastructure, permanent, preformed
NP UCLA Abutment Waxing Sleeve, Hexed by Sterngold Dental LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K933193 also covers:
- 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sterngold Dental LLC
Sources (1)
- FDA UDI bf3fb141-6a15-4136-88b4-1e2576525952 35 fields · synced May 30, 2026