Identity
- Trade Name
- Olympian-M Temporary Cement, Syringe Part B FDA UDI
- Generic Name
- Fatty acid dental cement FDA UDI
- Device Name
- Olympian M is used for cementating temporary crowns and splints. Retention of temporary crowns, sealing dressing in teeth during root canal therapy procedures.Trial cementation of permanent restorations prior to final insertion.Testing of interproximal contacts prior to final placement. FDA UDI
- Model / Reference
- 0003 FDA UDI
- Description
- Olympian M is used for cementating temporary crowns and splints. Retention of temporary crowns, sealing dressing in teeth during root canal therapy procedures.Trial cementation of permanent restorations prior to final insertion.Testing of interproximal contacts prior to final placement. FDA UDI
Identifiers
- Catalog Number
- 0003 FDA UDI
- Primary DI / UDI-DI
- D83600030 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
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: Fatty acid dental cement
Olympian-M Temporary Cement, Syringe Part B by Dent Zar, 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
- Dent Zar, Inc.
Sources (1)
- FDA UDI 155415a6-cb26-4d91-84ab-7b49ecf65238 34 fields · synced May 30, 2026