Identity
- Trade Name
- CHEMFIL ROCK FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- CHEMFIL ROCK A4-O REFILL is a high-strength zinc-reinforced glass ionomer restorative in capsule delivery that can be bulk placed and is self cure setting. FDA UDI
- Model / Reference
- 60606594 FDA UDI
- Description
- CHEMFIL ROCK A4-O REFILL is a high-strength zinc-reinforced glass ionomer restorative in capsule delivery that can be bulk placed and is self cure setting. FDA UDI
Identifiers
- Catalog Number
- 60606594 FDA UDI
- Primary DI / UDI-DI
- D010606065941 FDA UDI
- FDA Product Code
- EBF FDA UDIEMA FDA UDIEBC FDA UDIEJK FDA UDI
- GMDN Term
- Glass ionomer dental cement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI872.3275 FDA UDI872.3765 FDA UDI872.3250 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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 0.12 Milliliter FDA UDIWeight — 442 Milligram FDA UDI
Chemfil Rock by Dentsply De Trey GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Dentsply De Trey GmbH
Sources (1)
- FDA UDI 0a9dbaf7-4c20-4cf2-8c4e-9cbc8c3675e7 36 fields · synced Jun 8, 2026