Identity
- Trade Name
- Dycal® Radiopaque Calcium Hydroxide Composition FDA UDI
- Generic Name
- Calcium hydroxide dental cement FDA UDI
- Device Name
- Dycal® Placement Instrument Refill FDA UDI
- Model / Reference
- 623117 FDA UDI
- Description
- Dycal® Placement Instrument Refill FDA UDI
Identifiers
- Catalog Number
- 623117 FDA UDI
- Primary DI / UDI-DI
- D0026231171 FDA UDI
- FDA Product Code
- DZN FDA UDI
- GMDN Term
- Calcium hydroxide dental cement 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
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
Category: Calcium hydroxide dental cement
Dycal® Radiopaque Calcium Hydroxide Composition by Dentsply International — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Dentsply International
Sources (1)
- FDA UDI 5d4ed41f-8bb5-4d24-9071-9ebb7ea27b05 37 fields · synced Jun 7, 2026