Identity
- Trade Name
- TRU® RP Healing Abutment .050" Hex 5.0 mmm, Ti FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Healing Abutments are intended for placement onto the implant during stage II surgery. As the tissue heals, it conforms to the contours of the abutment. As the gingiva heals, the tissue adapts to the form of the healing abutment, creating permanent oral access to the implant and prepares the gingiva for the restorative phase. FDA UDI
- Model / Reference
- 901440 FDA UDI
- Description
- Healing Abutments are intended for placement onto the implant during stage II surgery. As the tissue heals, it conforms to the contours of the abutment. As the gingiva heals, the tissue adapts to the form of the healing abutment, creating permanent oral access to the implant and prepares the gingiva for the restorative phase. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549107887 FDA UDI
- 510(k) Number
- K150968 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental implant suprastructure, permanent, preformed
TRU® RP Healing Abutment .050" Hex 5.0 mmm, Ti 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 |
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Manufacturer
- Manufacturer
- Sterngold Dental LLC
Sources (1)
- FDA UDI 88ee47d2-50f3-417c-89ac-4b5ed2e7edf0 35 fields · synced May 30, 2026