Identity
- Trade Name
- EnvoyCem® FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- EnvoyCem® Glass Ionmer Cement FDA UDI
- Model / Reference
- 1640 FDA UDI
- Description
- EnvoyCem® Glass Ionmer Cement FDA UDI
Identifiers
- Catalog Number
- 901640-103 FDA UDI
- Primary DI / UDI-DI
- 00812282020375 FDA UDI
- 510(k) Number
- K080032 FDA UDI
- FDA Product Code
- NEA FDA UDI
- GMDN Term
- Glass ionomer dental cement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Glass ionomer dental cement
EnvoyCem® by Envoy Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Envoy Medical Corporation
Sources (1)
- FDA UDI f98fba45-2d82-4031-a99d-f1750f6a5c02 37 fields · synced May 31, 2026