Identity
- Trade Name
- CERASMART® FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- CERASMART® for Planmill 14 B1HT 5 pieces FDA UDI
- Model / Reference
- 008379 FDA UDI
- Description
- CERASMART® for Planmill 14 B1HT 5 pieces FDA UDI
Identifiers
- Catalog Number
- 008379 FDA UDI
- Primary DI / UDI-DI
- D0470083791 FDA UDI
- 510(k) Number
- K133824 FDA UDI
- FDA Product Code
- EBF FDA UDIEBG FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI872.3770 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Category: Dental implant suprastructure, permanent, preformed
Cerasmart® by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
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- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K133824 also covers:
- CERASMART® — Gc America Inc.
- CERASMART® — Gc America Inc.
- CERASMART® — Gc America Inc.
- CERASMART® — Gc America Inc.
- CERASMART® — Gc America Inc.
- CERASMART® — Gc America Inc.
- CERASMART® — Gc America Inc.
- CERASMART® — Gc America Inc.
- CERASMART® — Gc America Inc.
- CERASMART® — Gc America Inc.
- CERASMART® — Gc America Inc.
- CERASMART® — Gc America Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gc America Inc.
Sources (1)
- FDA UDI efca94c6-5c9b-43db-a003-84435b3930c4 37 fields · synced Jun 8, 2026