Identity
- Trade Name
- ERA® Micro Ovd. Metal Jacket FDA UDI
- Generic Name
- Resilient dental precision attachment FDA UDI
- Device Name
- Product is made of Stainless Steel for soldering and/or laser welding directly to frameworks. Attachments are two-part connectors. One part is intraorally fixed as part of a fixed (i.e. not patient removable) dental restoration, and a replaceable, high density nylon male anchored into a patient removable dental prosthesis (denture base). When the removable prosthesis is seated in the mouth the attachment parts come together and secure it in place. In other applications the attachment connects two sections of a segmented fixed partial denture. FDA UDI
- Model / Reference
- 811043 FDA UDI
- Description
- Product is made of Stainless Steel for soldering and/or laser welding directly to frameworks. Attachments are two-part connectors. One part is intraorally fixed as part of a fixed (i.e. not patient removable) dental restoration, and a replaceable, high density nylon male anchored into a patient removable dental prosthesis (denture base). When the removable prosthesis is seated in the mouth the attachment parts come together and secure it in place. In other applications the attachment connects two sections of a segmented fixed partial denture. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549100857 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 Ovd. Metal Jacket 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 5° 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
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 fd782d35-2963-4ba0-b11f-0689350d09e1 35 fields · synced May 30, 2026