Identity
- Trade Name
- TRU® Ti Base NP FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Ti Bases can be used for all ceramic restorations, crowns, either single unit bridges, milled bars, or hybrids. Ti Bases are attached to an implant as a prosthetic titanium base for attachment to implant abutments in order to restore function and esthetics in the oral cavity. FDA UDI
- Model / Reference
- 904758 FDA UDI
- Description
- Ti Bases can be used for all ceramic restorations, crowns, either single unit bridges, milled bars, or hybrids. Ti Bases are attached to an implant as a prosthetic titanium base for attachment to implant abutments in order to restore function and esthetics in the oral cavity. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549113406 FDA UDI
- 510(k) Number
- K150968 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
TRU® Ti Base NP 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.
- 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
K150968 also covers:
- TRU NP Implant 3.5 x 8mm, Ti — Sterngold Dental LLC
- TRU NP Implant 3.5x10mm, Ti — Sterngold Dental LLC
- TRU NP Implant 3.5x12mm, Ti — Sterngold Dental LLC
- TRU NP Implant 3.5x14mm, Ti — Sterngold Dental LLC
- TRU RP Implant 4.3X10mm, Ti — Sterngold Dental LLC
- TRU RP Implant 4.3X8MM, Ti — Sterngold Dental LLC
- TRU RP Implant 4.3x12mm, Ti — Sterngold Dental LLC
- TRU RP Implant 4.3x14mm, Ti — Sterngold Dental LLC
- TRU RP Implant 5.0x10mm, Ti — Sterngold Dental LLC
- TRU RP Implant 5.0x12mm, Ti — Sterngold Dental LLC
- TRU RP Implant 5.0x8mm, Ti — Sterngold Dental LLC
- TRU RP Implant 6.0x10mm, 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 bf44694a-929c-4762-94b7-743927b56e15 35 fields · synced May 31, 2026