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SIN Zirconia
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref SZTC2030Ref SZTC1018Ref SZTA3012Ref SZTA1014Ref SZTD4025Ref SZTC2012
Identity
- Trade Name
- SIN Zirconia T EUDAMEDSIN Zirconia FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- Dental restorative devices EUDAMED
- Model / Reference
- SZTA3012 EUDAMEDFDA UDISZTC2030 EUDAMEDFDA UDISZTC1018 EUDAMEDFDA UDISZTA1014 EUDAMEDFDA UDISZTC2012 EUDAMEDFDA UDISZTD4025 EUDAMEDFDA UDISZEC1214 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04251366915583 EUDAMEDFDA UDI04251366916283 EUDAMEDFDA UDI04251366916177 EUDAMEDFDA UDI04251366915439 EUDAMEDFDA UDI04251366916221 EUDAMEDFDA UDI04251366916672 EUDAMEDFDA UDI04251366915132 FDA UDI
- Basic UDI-DI
- 42513669ZRO2RQ EUDAMED
- 510(k) Number
- K100250 FDA UDI
- FDA Product Code
- EIH FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class IIb 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
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental appliance fabrication material, ceramic
SIN Zirconia by Pritidenta GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental appliance fabrication material, ceramic.
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- Multi M Series — DMAX Co., Ltd. · Class II
- Multi M Series — DMAX Co., Ltd. · Class II
- BruxZir Shaded 16 PLUS — PRISMATIK DENTALCRAFT, INC. · Class II
- CGI — CERAGROUP INDUSTRIES · Class II
- ARENA Star — ARUM DENTISTRY Co., Ltd. · Class II
Cleared under the same submission
K100250 also covers:
- GC Initial Zirconia Disk — Pritidenta GmbH
- GC Initial Zirconia Disk — Pritidenta GmbH
- GC Initial Zirconia Disk — Pritidenta GmbH
- GC Initial Zirconia Disk — Pritidenta GmbH
- GC Initial Zirconia Disk — Pritidenta GmbH
- GC Initial Zirconia Disk — Pritidenta GmbH
- GC Initial Zirconia Disk — Pritidenta GmbH
- GC Initial Zirconia Disk — Pritidenta GmbH
- GC Initial Zirconia Disk — Pritidenta GmbH
- SIN Zirconia — Pritidenta GmbH
- SIN Zirconia — Pritidenta GmbH
- SIN Zirconia — Pritidenta GmbH
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- Pritidenta GmbH
Sources (13)
- FDA UDI 4ac25222-24f7-487e-a393-c51fbd7abef8 33 fields · synced Aug 1, 2026
- FDA UDI 3046a7ec-6e5f-4c28-9ec5-8098dd4d79cc 33 fields · synced May 30, 2026
- FDA UDI 5225ff3c-1c1b-40f3-9d61-91253639b93f 33 fields · synced May 30, 2026
- FDA UDI 69ae6a5e-8095-47af-97be-f63a00de5a4b 33 fields · synced May 30, 2026
- FDA UDI 75b092d8-3a10-4949-a62f-a4baf521edae 33 fields · synced May 30, 2026
- FDA UDI 464f1061-d192-4f1a-990a-4b8cb1ab8be7 33 fields · synced May 30, 2026
- FDA UDI b0923ba0-9ae4-443b-98d3-bd3fd3405aac 33 fields · synced May 30, 2026
- EUDAMED e7634c13-65f4-47eb-b89e-9e1a4dc3334b 61 fields · synced Jul 8, 2026
- EUDAMED 81854444-5aaa-4c4c-baef-2abbe0082613 61 fields · synced Jul 8, 2026
- EUDAMED fd039dc1-aa15-46b0-a9f3-a2362fe398c8 61 fields · synced Jul 8, 2026
- EUDAMED dd4d3ebe-2010-4b2e-92af-282027c79f64 61 fields · synced Jul 8, 2026
- EUDAMED a66a1e13-f262-4825-847c-60d7794ca2de 61 fields · synced Jul 9, 2026
- EUDAMED b3c1d509-4ed8-462b-9b26-f772b9b9db9a 61 fields · synced Aug 1, 2026