Straumann n!ce Glass Ceramic A14 Blocks
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- n!ce Glass Ceramic Blocks for Amann Girrbach FDA UDIn!ce for Planmill FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- N!ce EUDAMEDn!ce®, HT A2, C14 FDA UDIn!ce® for PlanMill®, LT A1, C14 FDA UDIn!ce® for PlanMill®, LT D2, C14 FDA UDIn!ce® for PlanMill®, LT A2, C14 FDA UDIn!ce® for PlanMill®, LT B4, C14 FDA UDI
- Model / Reference
- 010.7141 EUDAMED010.7055 EUDAMED010.7149 EUDAMED010.7140 EUDAMED010.7144 EUDAMEDMilling Materials FDA UDI
- Description
- n!ce®, HT A2, C14 FDA UDIn!ce® for PlanMill®, LT A1, C14 FDA UDIn!ce® for PlanMill®, LT D2, C14 FDA UDIn!ce® for PlanMill®, LT A2, C14 FDA UDIn!ce® for PlanMill®, LT B4, C14 FDA UDI
Identifiers
- Catalog Number
- 010.7055 FDA UDI010.7140 FDA UDI010.7149 FDA UDI010.7141 FDA UDI010.7144 FDA UDI
- Primary DI / UDI-DI
- 07630031731043 EUDAMEDFDA UDI07630031734938 EUDAMEDFDA UDI07630031735027 EUDAMEDFDA UDI07630031734945 EUDAMEDFDA UDI07630031734976 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763003170001Q4 EUDAMED
- Unit of Use DI
- 07630031748140 EUDAMED07630031748058 EUDAMED07630031775290 EUDAMED07630031748133 EUDAMED07630031748171 EUDAMED
- FDA Product Code
- NHA FDA 510(k)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 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 872.3630 FDA 510(k)
- Regulation Number
- 872.3630 FDA 510(k)872.6660 FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The Straumann n!ce Glass Ceramic A14 Blocks are ceramic mesostructures designed for dental restorations. These blocks are intended for milling into crowns, partial crowns, inlays, onlays, or veneers, providing esthetic solutions for single-tooth restorations.
These blocks are supplied as non-sterile, single-use dental materials and are used in conjunction with endosseous dental implants and Ti-base abutments. They are classified under FDA Product Code NHA (Dental) and have received FDA 510(k) clearance (K171773) as substantially equivalent to a predicate device. The device is regulated under the MDR and intended for use in dental clinical settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Straumann n!ce Glass Ceramic A14 Blocks (K171773) — FDA 510 (k ..., Straumann® n!ce™ | Glass-Ceramic | Esthetic Dental Restorations, K171773 FDA 510 (k) - Straumann n!ce Glass Ceramic A14 Blocks, Straumann n!ce Glass Ceramic A14 Blocks - medequipdirectory.com, PDF Straumann n!ce Product Information
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K171773 | Class II | Active |
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Manufacturer
- Manufacturer
- Institut Straumann AG
Sources (11)
- FDA 510(k) K171773 24 fields · synced Sep 18, 2026
- FDA UDI a441e0b6-b472-45b4-ae45-da810008d628 35 fields · synced May 30, 2026
- FDA UDI 07c13f9e-3555-4049-a953-cc563930fb22 36 fields · synced May 30, 2026
- FDA UDI 8d10d956-f666-43bf-bb0e-92f4f8fa0bb4 37 fields · synced May 30, 2026
- FDA UDI 5ff63e0c-fdbd-487c-b81b-17539d11008c 36 fields · synced May 30, 2026
- FDA UDI 83aa7445-4764-448f-a5d4-90e4d3a5050b 36 fields · synced May 30, 2026
- EUDAMED 8cabe338-3243-4edb-8e64-3f24387856cd 61 fields · synced Jul 10, 2026
- EUDAMED e3e18496-566c-4c96-afdc-943c542dd1ef 61 fields · synced Jul 14, 2026
- EUDAMED 84b9fdbd-1a18-4d8f-b51f-33a7c527fbe6 61 fields · synced Jul 15, 2026
- EUDAMED 147797f1-1981-454f-b373-ce860614d7ca 61 fields · synced Jul 15, 2026
- EUDAMED 35ef9b91-b07a-4cb4-96c1-1d481c26b8a3 61 fields · synced Jul 26, 2026