Identity
- Trade Name
- ceraMotion® FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- ceraMotion® Ti Base Dentin C1, 20 g / dental ceramic material FDA UDI
- Model / Reference
- 251-030-20 FDA UDI
- Description
- ceraMotion® Ti Base Dentin C1, 20 g / dental ceramic material FDA UDI
Identifiers
- Primary DI / UDI-DI
- J011251030200 FDA UDI
- 510(k) Number
- K011425 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 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
No
FDA UDI
Category: Dental appliance fabrication material, ceramic
ceraMotion® by Dentaurum — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental appliance fabrication material, ceramic.
- Razor / MegaPlus — U&C International Co., Ltd · Class II
- rainbow High shine — Genoss · Class II
- Bloomden — Bloomden Bioceramics (Hunan) Co., Ltd. · Class II
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- Multi M Series — DMAX Co., Ltd. · Class II
- BruxZir Shaded 16 PLUS — PRISMATIK DENTALCRAFT, INC. · Class II
- CGI — CERAGROUP INDUSTRIES · Class II
- ARENA Star — ARUM DENTISTRY Co., Ltd. · Class II
Cleared under the same submission
K011425 also covers:
- Aidite — Aidite (Qinhuangdao) Technology Co., Ltd.
- Aidite — Aidite (Qinhuangdao) Technology Co., Ltd.
- Carmen® — Dentaurum
- Carmen® — Dentaurum
- ceraMotion® — Dentaurum
- ceraMotion® — Dentaurum
- ceraMotion® — Dentaurum
- ceraMotion® — Dentaurum
- ceraMotion® — Dentaurum
- ceraMotion® — Dentaurum
- ceraMotion® — Dentaurum
- ceraMotion® — Dentaurum
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
- Dentaurum
Sources (1)
- FDA UDI 2b3d1364-a2b1-4e9c-af2c-976b365dc950 36 fields · synced May 31, 2026