Identity
- Trade Name
- Flexi-Overdenture FDA UDI
- Generic Name
- Denture clasp, polymer, preformed FDA UDI
- Device Name
- Flexi-Overdenture EZ-Change Cap Inserts FDA UDI
- Model / Reference
- 250-02 FDA UDI
- Description
- Flexi-Overdenture EZ-Change Cap Inserts FDA UDI
Identifiers
- Catalog Number
- 250-02 FDA UDI
- Primary DI / UDI-DI
- 00766054001935 FDA UDI
- FDA Product Code
- EIY FDA UDI
- GMDN Term
- Denture clasp, polymer, preformed FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Denture clasp, polymer, preformed
Flexi-Overdenture by Essential Dental Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Denture clasp, polymer, preformed.
- Preat Implant Prosthetics — PREAT Corporation · Class I
- WHITE O-RING — Oco Biomedical · Class I
- RETAINING RING WITH O-RING — Oco Biomedical · Class I
- RED O-RING — Oco Biomedical · Class I
- LARGE WHITE O-RING — Oco Biomedical · Class I
- 002 BLACK O-RING — Oco Biomedical · Class I
- HOUSING CAP WITH O-RING — Oco Biomedical · Class I
- RETAINING RING — Oco Biomedical · Class I
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
- Essential Dental Systems, Inc.
Sources (1)
- FDA UDI b4a5b489-aad7-4439-8e26-ef37908d9983 35 fields · synced Jun 1, 2026