Identity
- Trade Name
- ERA® Micro 5° Female FDA UDI
- Generic Name
- Resilient dental precision attachment 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
- 811213 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
- 00841549101229 FDA UDI
- 510(k) Number
- K020391 FDA UDI
- FDA Product Code
- EGG FDA UDI
- GMDN Term
- Resilient dental precision attachment FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3165 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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: Resilient dental precision attachment
ERA® Micro 5° Female by Sterngold Dental LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K020391 also covers:
- ERA® Implant Abutment Micro Male Package Complete — Sterngold Dental LLC
- ERA® Micro 0° Female — Sterngold Dental LLC
- ERA® Micro 11° Female — Sterngold Dental LLC
- ERA® Micro 17° Female — Sterngold Dental LLC
- ERA® Micro 23° Female — Sterngold Dental LLC
- ERA® Micro 30° Female — Sterngold Dental LLC
- ERA® Micro DE Female SS — Sterngold Dental LLC
- ERA® Micro IA Male Package (5) — Sterngold Dental LLC
- ERA® Micro Laser Weldable Female SS — Sterngold Dental LLC
- ERA® Micro Laser Weldable Female Ti — Sterngold Dental LLC
- ERA® Micro Ovd. Basic Pros. Kit — Sterngold Dental LLC
- ERA® Micro Ovd. Males Assorted (7) — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sterngold Dental LLC
Sources (1)
- FDA UDI b9b0a0bb-84b3-43ab-a511-08929fded406 35 fields · synced Jun 1, 2026