Identity
- Trade Name
- ERA® Std. OV Attachment-Kodent FDA UDI
- Generic Name
- Resilient dental precision attachment FDA UDI
- Device Name
- Resilient semi-precision attachment. Contents: 1 female and 2-Black males 2-white males, and 1 orange male. 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 FDA UDI
- Model / Reference
- 811310K FDA UDI
- Description
- Resilient semi-precision attachment. Contents: 1 female and 2-Black males 2-white males, and 1 orange male. 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 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549101625 FDA UDI
- 510(k) Number
- K913348 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Resilient dental precision attachment FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- Not 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
ERA® Std. OV Attachment-Kodent by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sterngold Dental LLC
Sources (1)
- FDA UDI 2bdddd90-57ed-40ea-9633-87d4ce392d04 36 fields · synced Jun 8, 2026