Identity
- Trade Name
- TRU Prosthetic Screw RP .048 Hex FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- TRU Prosthetic Screw RP .048" Hex. These Prosthetic Screws are intended for fixation of abutment to dental implant. They are made from titanium 6AL-4V ELI material. FDA UDI
- Model / Reference
- 904721 FDA UDI
- Description
- TRU Prosthetic Screw RP .048" Hex. These Prosthetic Screws are intended for fixation of abutment to dental implant. They are made from titanium 6AL-4V ELI material. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549113345 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
- 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
TRU Prosthetic Screw RP .048 Hex by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 1122f0d2-bfde-4f49-bc33-be5228f87e03 36 fields · synced Jun 6, 2026