Identity
- Trade Name
- ERA® Standard 5° Female FDA UDI
- Generic Name
- Resilient dental precision attachment FDA UDI
- Device Name
- ERA® Standard 5° Female. 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
- 811601 FDA UDI
- Description
- ERA® Standard 5° Female. 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
- 00841549102189 FDA UDI
- 510(k) Number
- K921010 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Resilient dental precision attachment 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
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® Standard 5° Female by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K921010 also covers:
- ERA Implant Abutment Std Ang Base, 3mm Cuff (AE) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base 1mm(X) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base 3mm(X) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base, 0.6mm Cuff (B) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base, 0.7mm Cuff (AX) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base, 1.75mm Cuff(AR) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base, 1mm Cuff (AC) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base, 1mm Cuff (AT) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base, 1mm Cuff (BG) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base, 1mm Cuff (D) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base, 1mm Cuff (Z) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base, 2.25mm Cuff (AE) — 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 aa6ae57f-eea0-4bb3-9f56-b42003de9c7f 35 fields · synced May 31, 2026