Identity
- Trade Name
- n!ce Glass Ceramic Blocks FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- N!ce EUDAMEDn!ce® C, LT A3, C14 FDA UDIn!ce® C, LT A3 & HT A3, C14 FDA UDI
- Model / Reference
- 010.7061 EUDAMED010.7067 EUDAMEDMilling Materials FDA UDI
- Description
- n!ce® C, LT A3, C14 FDA UDIn!ce® C, LT A3 & HT A3, C14 FDA UDI
Identifiers
- Catalog Number
- 010.7061 FDA UDI010.7067 FDA UDI
- Primary DI / UDI-DI
- 07630031738646 EUDAMEDFDA UDI07630031738707 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763003170001Q4 EUDAMED
- FDA Product Code
- EIH FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDIFDA 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
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
N!ce by Institut Straumann AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0763003170001Q4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Institut Straumann AG
- EUDAMED SRN
- CH-MF-000009933
- Authorised Representative
- Etkon GmbH DE-AR-000009335
Sources (4)
- EUDAMED 0c204f19-fa14-4f64-95b3-3b47e07d136b 61 fields · synced Sep 17, 2026
- FDA UDI 10f012df-2c73-4f27-9067-ebe24887d7d0 35 fields · synced May 30, 2026
- FDA UDI 9743a161-9c4f-4ff5-b37f-a8094d72decd 35 fields · synced May 30, 2026
- EUDAMED 80f46980-8127-4fa2-af90-f7c39a6cfe60 61 fields · synced Jul 18, 2026