Identity
- Trade Name
- Abutment Base 3.0mm (T) FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into Abutment Bases which are screwed into endosseous implants. FDA UDI
- Model / Reference
- 904937 FDA UDI
- Description
- Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into Abutment Bases which are screwed into endosseous implants. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549114281 FDA UDI
- 510(k) Number
- K130183 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
- 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
Abutment Base 3.0mm (T) by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
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Cleared under the same submission
K130183 also covers:
- Abutment Base 0.75mm (S) — Sterngold Dental LLC
- Abutment Base 1.75mm (X) — Sterngold Dental LLC
- Abutment Base 2.5mm (B) — Sterngold Dental LLC
- Abutment Base 4.5mm (B) — Sterngold Dental LLC
- Abutment Base 5.0mm (C) — Sterngold Dental LLC
- Abutment Base 5.0mm (S) — Sterngold Dental LLC
- Abutment Base 5.0mm (Z) — Sterngold Dental LLC
- Stern Snap Abutment Base 1.75mm (S) — Sterngold Dental LLC
- Stern Snap Abutment Base 1.75mm (T) — Sterngold Dental LLC
- Stern Snap Abutment Base 1.75mm (Z) — Sterngold Dental LLC
- Stern Snap Abutment Base 3.0mm (C) — Sterngold Dental LLC
- Stern Snap Abutment Base 3.0mm (S) — 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 72bb6508-e383-4b0c-952c-7699a01ab443 35 fields · synced May 31, 2026