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N!ce

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 010.7057

by Institut Straumann AG

Identity

Trade Name
n!ce Glass Ceramic Blocks for Amann Girrbach FDA UDI
Generic Name
Dental appliance fabrication material, ceramic FDA UDI
Device Name
N!ce EUDAMED
n!ce®, HT B2, C14 FDA UDI
Model / Reference
010.7057 EUDAMED
Milling Materials FDA UDI
Description
n!ce®, HT B2, C14 FDA UDI

Identifiers

Catalog Number
010.7057 FDA UDI
Primary DI / UDI-DI
07630031731067 EUDAMEDFDA UDI
Basic UDI-DI
0763003170001Q4 EUDAMED
Unit of Use DI
07630031748072 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 EUDAMED
Class 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 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
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

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Manufacturer

Manufacturer
Institut Straumann AG
EUDAMED SRN
CH-MF-000009933
Authorised Representative
Etkon GmbH DE-AR-000009335

Sources (2)

  • EUDAMED 8127aa71-c76f-4b23-83a0-f5075c56e1fa 61 fields · synced Jul 14, 2026
  • FDA UDI 4fe9842a-c1ef-4957-8671-537a02972df5 35 fields · synced May 30, 2026