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N!ce block
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 010.7033Ref 010.7027Ref 010.7117Ref 010.7032Ref 010.7024Ref 010.7120Ref 010.7127Ref 010.7025Ref 010.7118Ref 010.7031Ref 010.7040Ref 010.7044Ref 010.7030Ref 010.7128Ref 010.7122
Identity
- Trade Name
- Straumann n!ce Glass Ceramic A14 Blocks FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- N!ce block EUDAMEDn!ce® C, HT Bleach, A14L FDA UDIn!ce® C, LT D2, A14L FDA UDIn!ce® C, LT B4, A14L FDA UDIn!ce® C, HT A3, A14L FDA UDI
- Model / Reference
- 010.7033 EUDAMED010.7027 EUDAMED010.7117 EUDAMED010.7032 EUDAMED010.7024 EUDAMED010.7120 EUDAMED010.7127 EUDAMED010.7025 EUDAMED010.7118 EUDAMED010.7031 EUDAMED010.7040 EUDAMED010.7044 EUDAMED010.7030 EUDAMED010.7128 EUDAMED010.7122 EUDAMEDMilling Materials FDA UDI
- Description
- n!ce® C, HT Bleach, A14L FDA UDIn!ce® C, LT D2, A14L FDA UDIn!ce® C, LT B4, A14L FDA UDIn!ce® C, HT A3, A14L FDA UDI
Identifiers
- Catalog Number
- 010.7128 FDA UDI010.7127 FDA UDI010.7040 FDA UDI010.7044 FDA UDI
- Primary DI / UDI-DI
- 07630031731623 EUDAMED07630031731562 EUDAMED07630031734709 EUDAMED07630031731616 EUDAMED07630031731869 EUDAMED07630031734730 EUDAMED07630031734808 EUDAMEDFDA UDI07630031731876 EUDAMED07630031734716 EUDAMED07630031731609 EUDAMED07630031734815 EUDAMEDFDA UDI07630031731692 EUDAMEDFDA UDI07630031731739 EUDAMEDFDA UDI07630031731593 EUDAMED07630031734754 EUDAMED
- Basic UDI-DI
- 0763003170005QC EUDAMED
- Unit of Use DI
- 07630031747716 EUDAMED07630031747624 EUDAMED07630031747662 EUDAMED07630031747709 EUDAMED07630031747594 EUDAMED07630031747747 EUDAMED07630031775252 EUDAMED07630031747600 EUDAMED07630031747679 EUDAMED07630031747693 EUDAMED07630031747815 EUDAMED07630031747884 EUDAMED07630031747686 EUDAMED07630031747921 EUDAMED07630031747761 EUDAMED
- FDA Product Code
- NHA 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
- 872.3630 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 UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
N!ce block 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 | 0763003170005QC | 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 (19)
- EUDAMED af20e189-a2e7-4bd1-b004-ea047e83ac3c 61 fields · synced Aug 4, 2026
- EUDAMED b04c4e4c-00d5-4747-a401-be2217a6633a 61 fields · synced May 16, 2026
- EUDAMED 791be875-0daf-4d44-a3c7-b4d103c19a4e 61 fields · synced May 17, 2026
- EUDAMED 13e267ab-0d23-49d8-b3b6-775bf3dc15ce 61 fields · synced May 17, 2026
- EUDAMED 7c50a193-0ac3-45b1-b7ba-5a8b41799a34 61 fields · synced May 17, 2026
- EUDAMED dd6a913e-52b2-4b1a-9526-1343747bd3f0 61 fields · synced May 18, 2026
- EUDAMED 54f3bde0-bd9b-460a-a542-e988ec885552 61 fields · synced May 18, 2026
- EUDAMED 83506add-508f-4c37-b388-8b6a77ef1cc0 61 fields · synced May 18, 2026
- EUDAMED b34598a0-ae0c-4f15-9341-ec3bfd2f245c 61 fields · synced May 18, 2026
- EUDAMED 9dcee280-7770-4165-985a-bb883bdd4123 61 fields · synced May 18, 2026
- FDA UDI 0db6aec8-deb9-4053-9a3c-e4d8f0c84504 35 fields · synced May 30, 2026
- FDA UDI 838ebd87-292c-4ff5-9985-a63518e86c38 36 fields · synced May 30, 2026
- FDA UDI 9fac3fad-642a-4fd2-8b51-3b53c217a439 35 fields · synced May 30, 2026
- FDA UDI 639ec93b-96f1-4cc5-abcb-55fbf0b8e2e9 35 fields · synced May 30, 2026
- EUDAMED bfeff776-e59e-4749-b772-6b2696bf8bc5 61 fields · synced Jul 13, 2026
- EUDAMED 3838032b-2461-4924-b888-edb405a8d9c4 61 fields · synced Jul 14, 2026
- EUDAMED 2ac54636-5d94-48b4-a066-cbc66ed6404f 61 fields · synced Jul 16, 2026
- EUDAMED a6411c98-2f9e-4078-a0b9-9b6cf51b5cfd 61 fields · synced Jul 19, 2026
- EUDAMED 0ba1f82c-553a-47bb-92fd-fa78e35f21af 61 fields · synced Jul 19, 2026