Identity
- Trade Name
- ERA® Implant Abutment Standard 0°, 2mm Cuff (B) FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Implant retained overdentures are an established treatment modality. 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
- 811802 FDA UDI
- Description
- Implant retained overdentures are an established treatment modality. 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
- 00841549102370 FDA UDI
- 510(k) Number
- K914764 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
- 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
MR Conditional FDA UDI
Category: Dental implant suprastructure, permanent, preformed
ERA® Implant Abutment Standard 0°, 2mm Cuff (B) by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
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- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K914764 also covers:
- ERA Implant Abutment Std 0 Deg, 2mm Cuff (AE) — Sterngold Dental LLC
- ERA Implant Abutment Std 0 Deg, 3mm Cuff (AE) — Sterngold Dental LLC
- ERA Implant Abutment Std 0 Deg, 4mm Cuff (AE) — Sterngold Dental LLC
- ERA® Implant Abutment Micro 0°, 0.5mm Cuff (AC) — Sterngold Dental LLC
- ERA® Implant Abutment Micro 0°, 0.5mm Cuff (B) — Sterngold Dental LLC
- ERA® Implant Abutment Micro 0°, 0.5mm Cuff (D) — Sterngold Dental LLC
- ERA® Implant Abutment Micro 0°, 0.7mm Cuff (AX) — Sterngold Dental LLC
- ERA® Implant Abutment Micro 0°, 1.2mm Cuff (AR) — Sterngold Dental LLC
- ERA® Implant Abutment Micro 0°, 1.2mm Cuff (AS) — Sterngold Dental LLC
- ERA® Implant Abutment Micro 0°, 1mm Cuff (AQ) — Sterngold Dental LLC
- ERA® Implant Abutment Micro 0°, 1mm Cuff (AT) — Sterngold Dental LLC
- ERA® Implant Abutment Micro 0°, 1mm Cuff (AY) — 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 466d11d3-181b-4c20-880f-3252d1a868f9 35 fields · synced May 30, 2026