Identity
- Trade Name
- ERA® Implant Abutment Standard 17° Female only FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant). FDA UDI
- Model / Reference
- 811099 FDA UDI
- Description
- ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549100987 FDA UDI
- 510(k) Number
- K913348 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
ERA® Implant Abutment Standard 17° Female only by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K913348 also covers:
- ERA® 0° DO Small Post Attachment SS — Sterngold Dental LLC
- ERA® 0° DO Small Post Female SS — Sterngold Dental LLC
- ERA® 11° DO Large Post Female SS — Sterngold Dental LLC
- ERA® 11° DO Small Post Attachment SS — Sterngold Dental LLC
- ERA® 11° DO Small Post Female SS — Sterngold Dental LLC
- ERA® 17° DO Large Post Female SS — Sterngold Dental LLC
- ERA® 17° DO Small Post Attachment SS — Sterngold Dental LLC
- ERA® 17° DO Small Post Female SS — Sterngold Dental LLC
- ERA® 5° DO Large Post Attachment SS — Sterngold Dental LLC
- ERA® 5° DO Small Post Attachment SS — Sterngold Dental LLC
- ERA® 5° DO Small Post Female SS — Sterngold Dental LLC
- ERA® DO SP Master Kit w/ Tools SS — 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 cb1c3dec-20fd-4fd4-9922-fb1f4b95cbd9 35 fields · synced Jun 6, 2026