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ERA® Implant Abutment Micro Angled Base, 6mm Cuff (X)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- ERA® Implant Abutment Micro Angled Base, 6mm Cuff (X) 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
- 812816 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
- 00841549104886 FDA UDI
- 510(k) Number
- K092434 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
Category: Dental implant suprastructure, permanent, preformed
ERA® Implant Abutment Micro Angled Base, 6mm Cuff (X) 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.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- 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
K092434 also covers:
- ERA® Implant Abutment Micro Ang. Base, .5mm Cuff (AL) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base, 1mm Cuff (AH) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base, 1mm Cuff (AN) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base, 1mm Cuff (AP) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (AH) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (AJ) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (AK) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (AL) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (AP) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (BD) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (BE) — Sterngold Dental LLC
- ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (S) — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sterngold Dental LLC
Sources (1)
- FDA UDI 39577860-9d84-4f61-ab0e-3c911679692e 35 fields · synced May 31, 2026