Identity
- Trade Name
- TRU® Prosthetic Screw NP .050" Hex, Ti FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw FDA UDI
- Device Name
- TRU Prosthetic Screw NP .048" Hex. The TRU Prosthetic Screws are intended for fixation of abutment to dental implant. They are made from titanium 6AL-4V ELI material. FDA UDI
- Model / Reference
- 904656 FDA UDI
- Description
- TRU Prosthetic Screw NP .048" Hex. The TRU 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
- 00841549112867 FDA UDI
- 510(k) Number
- K150968 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental prosthesis/implant abutment screw 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 prosthesis/implant abutment screw
TRU® Prosthetic Screw NP .050" Hex, Ti by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis/implant abutment screw.
- Azure — TERRATS MEDICAL SL. · Class II
- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class II
- Implant Prosthetics — PREAT Corporation · Class II
- INNO Submerged Implant System-Cemented Abutment — Cowellmedi Co., Ltd · Class II
- MEDENTiKA — Medentika GmbH · Class II
- Azure — TERRATS MEDICAL SL. · 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 acd970f3-4f8a-4db5-b326-215277f559b1 35 fields · synced Jun 1, 2026