Identity
- Trade Name
- ERA® Micro Partial Males Orange (5) FDA UDI
- Generic Name
- Resilient dental precision attachment FDA UDI
- Device Name
- 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
- 811015 FDA UDI
- Description
- 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
- 00841549100703 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Resilient dental precision attachment
ERA Micro Partial Males Orange (5) is a dental fixation device designed to provide sufficient mechanical play to withstand the variations in prosthesis seating due to tissue deformation, without placing excessive stress on abutments. This resilient dental precision attachment features two-part connectors that come together when a removable prosthesis is seated, ensuring secure and stable positioning. Developed by STERNGOLD DENTAL LLC, ERA Micro Partial Males Orange (5) is ideal for various applications in dentistry.
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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
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 3a281d6b-1dad-4ad1-a8a4-73d297181654 35 fields · synced Jun 24, 2026