Identity
- Trade Name
- ERA® RV Partial Metal Jacket FDA UDI
- Generic Name
- Resilient dental precision attachment FDA UDI
- Device Name
- ERA RV Partial. 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
- 811168 FDA UDI
- Description
- ERA RV Partial. 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
- 00841549101113 FDA UDI
- 510(k) Number
- K913348 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® RV Partial 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
K913348 also covers:
- ERA® 0° DO Small Post Attachment SS — Sterngold Dental LLC
- ERA® 0° DO Small Post Female SS — Sterngold Dental LLC
- ERA® 11° DO Large Post Female SS — Sterngold Dental LLC
- ERA® 11° DO Small Post Attachment SS — Sterngold Dental LLC
- ERA® 11° DO Small Post Female SS — Sterngold Dental LLC
- ERA® 17° DO Large Post Female SS — Sterngold Dental LLC
- ERA® 17° DO Small Post Attachment SS — Sterngold Dental LLC
- ERA® 17° DO Small Post Female SS — Sterngold Dental LLC
- ERA® 5° DO Large Post Attachment SS — Sterngold Dental LLC
- ERA® 5° DO Small Post Attachment SS — Sterngold Dental LLC
- ERA® 5° DO Small Post Female SS — Sterngold Dental LLC
- ERA® DO SP Master Kit w/ Tools SS — 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 e2283be3-6c0d-4a95-a33e-3540b0e65348 35 fields · synced May 31, 2026