Identity
- Trade Name
- SternSnap Complete Attachment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants. The SternSnap Attachment consists of a modified ball, which screws into an SFI Abutment and a retaining cap that gets processed into the denture. The retaining female engages the outside of the ball shape and allows retention of the prosthesis to the denture. FDA UDI
- Model / Reference
- 904127 FDA UDI
- Description
- The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants. The SternSnap Attachment consists of a modified ball, which screws into an SFI Abutment and a retaining cap that gets processed into the denture. The retaining female engages the outside of the ball shape and allows retention of the prosthesis to the denture. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549110399 FDA UDI
- 510(k) Number
- K150250 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
SternSnap Complete Attachment by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K150250 also covers:
- Stern Snap® Angled Screw — Sterngold Dental LLC
- Stern Snap® Retaining Cap Metal Free, Assorted (3) — Sterngold Dental LLC
- Stern Snap® Retaining Cap Metal Free, Brown, 3 pack — Sterngold Dental LLC
- Stern Snap® Retaining Cap Metal Free, Green, 3 pack — Sterngold Dental LLC
- Stern Snap® Retaining Cap Metal Free, Yellow, 3 pack — Sterngold Dental LLC
- SternSnap Angled Attachment — 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 38a8994a-22b0-4d07-b78f-68be1293f751 36 fields · synced Jun 8, 2026