Identity
- Trade Name
- n!ce® FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- n!ce® Paste 2D B (body) / dental ceramic material FDA UDI
- Model / Reference
- 256-025-03 FDA UDI
- Description
- n!ce® Paste 2D B (body) / dental ceramic material FDA UDI
Identifiers
- Primary DI / UDI-DI
- J011256025030 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
- Not 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
n!ce® by Dentaurum — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dentaurum
Sources (1)
- FDA UDI e89a2b0c-b3c2-4c75-96e5-277a9b6a0da1 37 fields · synced Jun 6, 2026