Identity
- Trade Name
- FREEGENOL™ FDA UDI
- Generic Name
- Fatty acid dental cement FDA UDI
- Device Name
- FREEGENOL™ Standard Package (55g base, 20g catalyst, & mixing pad) FDA UDI
- Model / Reference
- 136501 FDA UDI
- Description
- FREEGENOL™ Standard Package (55g base, 20g catalyst, & mixing pad) FDA UDI
Identifiers
- Catalog Number
- 136501 FDA UDI
- Primary DI / UDI-DI
- D6581365011 FDA UDI
- 510(k) Number
- K842994 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Fatty acid 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Fatty acid dental cement
Freegenol™ by Gc America Inc. — 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
- Gc America Inc.
Sources (1)
- FDA UDI b04a729d-a790-4b02-a4c0-8682d7ca86f4 37 fields · synced May 30, 2026