Identity
- Trade Name
- PUR Straight Abutment NP 1.5mm cuff - Titanium FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- PUR Straight Abutment NP 1.5mm cuff - Titanium. PUR Standard Abutments attach directly to the implant and provide the transitional link between the head of the implant and the restorative components. They are designed to be used for screw retained multi-implant prostheses. FDA UDI
- Model / Reference
- 904773 FDA UDI
- Description
- PUR Straight Abutment NP 1.5mm cuff - Titanium. PUR Standard Abutments attach directly to the implant and provide the transitional link between the head of the implant and the restorative components. They are designed to be used for screw retained multi-implant prostheses. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549113512 FDA UDI
- 510(k) Number
- K151928 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
PUR Straight Abutment NP 1.5mm cuff - Titanium 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
K151928 also covers:
- PUR NP Implant 3.5 x 10mm, Ti — Sterngold Dental LLC
- PUR NP Implant 3.5 x 12mm, Ti — Sterngold Dental LLC
- PUR NP Implant 3.5 x 14mm, Ti — Sterngold Dental LLC
- PUR NP Implant 3.5 x 8mm, Ti — Sterngold Dental LLC
- PUR NP Implant 4.3 x 10mm, Ti — Sterngold Dental LLC
- PUR NP Implant 4.3 x 12mm, Ti — Sterngold Dental LLC
- PUR NP Implant 4.3 x 14mm, Ti — Sterngold Dental LLC
- PUR NP Implant 4.3 x 8mm, Ti — Sterngold Dental LLC
- PUR NP Implant 5.0 x 10mm, Ti — Sterngold Dental LLC
- PUR NP Implant 5.0 x 12mm, Ti — Sterngold Dental LLC
- PUR NP Implant 5.0 x 8mm, Ti — Sterngold Dental LLC
- PUR NP Implant 6.0 x 10mm, 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 ef39fc80-64e0-4b15-b9c9-ca8e6ab2d88a 35 fields · synced May 30, 2026