Identity
- Trade Name
- CeraPutty CP05 FDA UDI
- Generic Name
- Hygroscopic dental cement FDA UDI
- Device Name
- CeraPutty (Bioceramic Root Repair Material) is a ready-to-use, premixed bioceramic root repair material developed for permanent root canal repair and filling applications. It is made of Calcium silicate composite, zirconium dioxide which is a radiopaque agent, and a thickening agent. CeraPutty sets and hardens by the moisture inside the oral cavity. CeraPutty does not shrink during setting and demonstrates excellent physical properties. CeraPutty does not require additional mixing for procedures, and its white color which allows aesthetic treatment. Ceraputty is packaged in a preloaded syringe. FDA UDI
- Model / Reference
- 6011 FDA UDI
- Description
- CeraPutty (Bioceramic Root Repair Material) is a ready-to-use, premixed bioceramic root repair material developed for permanent root canal repair and filling applications. It is made of Calcium silicate composite, zirconium dioxide which is a radiopaque agent, and a thickening agent. CeraPutty sets and hardens by the moisture inside the oral cavity. CeraPutty does not shrink during setting and demonstrates excellent physical properties. CeraPutty does not require additional mixing for procedures, and its white color which allows aesthetic treatment. Ceraputty is packaged in a preloaded syringe. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806387860112 FDA UDI
- 510(k) Number
- K232299 FDA UDI
- FDA Product Code
- KIF FDA UDI
- GMDN Term
- Hygroscopic dental cement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
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: Hygroscopic dental cement
CeraPutty CP05 by Meta Biomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hygroscopic dental cement.
- Avalon Biomed NeoSEALER Flo 2.2 g Refill Syringe — NUSMILE, LTD
- AH Plus BioCermanic Sealer — TULSA DENTAL PRODUCTS LLC · Class II
- MTA Flow — ULTRADENT PRODUCTS, INC. · Class II
- MAARC DENTAL -Rootfyx — Shiva Products · Class II
- Avalon Biomed NeoSEALER Flo Professional Kit 4.4 g - SAMPLE — NUSMILE, LTD
- Avalon Biomed NeoSEALER Flo Professional Kit 4.4 g — NUSMILE, LTD
- AH Plus BioCermanic Sealer — TULSA DENTAL PRODUCTS LLC · Class II
- Komet BioRepair — Angelus Industria de Produtos Odontologicos S A · Class II
Cleared under the same submission
K232299 also covers:
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
- Meta Biomed, Inc.
Sources (1)
- FDA UDI d1f4c765-2811-44bc-ab95-da2f4ab08216 34 fields · synced May 30, 2026