Identity
- Trade Name
- PUR NP Healing Abutment, 3.0mm, 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
- 901385 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
- 00841549107665 FDA UDI
- 510(k) Number
- K151928 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
- Not 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
PUR NP Healing Abutment, 3.0mm, Ti by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Sterngold Dental LLC
Sources (1)
- FDA UDI 58aed1f9-cdf0-485a-a58f-a581832ae6fd 36 fields · synced May 30, 2026