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Dental Zirconia Ceramics
EUDAMEDClass IIa (EU MDR)
Ref 06979063053749Model ST-PLUS-20Ref 06975168472010Model DHT-10Ref 06975168471082Model DUT-25Ref 06979063053787Model ST-PLUS-12Ref 06975168471037Model DUT-14Ref 06979063053640Model ST-25Ref 06975168473017Model DST-10Ref DD601458410001Model UT-14Ref 06975168474076Model UT-22Ref 06975168472065Model DHT-20Ref 06975168478685Model HT-25Ref 06975168478654Model HT-18Ref 06979063053671Model ST-18Ref 06975168472072Model DHT-22Ref 06975168471044Model DUT-16Ref 06975168474021Model UT-12Ref 06979063053701Model ST-12Ref 06979063053695Model ST-14Ref 06975168478661Model HT-20Ref 06979063053855Model 3D-PRO-14Ref 06979063053756Model ST-PLUS-18Ref 06979063053732Model ST-PLUS-22Ref 06979063053817Model 3D-PRO-22Ref 06975168472058Model DHT-18Ref 06975168478630Model HT-14Ref 06979063053770Model ST-PLUS-14Ref 06975168471013Model DUT-10Ref 06975168472089Model DHT-25Ref 06975168478623Model HT-12Ref 06979063053862Model 3D-PRO-12Ref 06979063053879Model 3D-PRO-10Ref 06979063053657Model ST-22Ref 06975168474069Model UT-20Ref 06979063053800Model 3D-PRO-25Ref 06975168471020Model DUT-12
Identity
- Trade Name
- Dental Zirconia Ceramics EUDAMED
- Device Name
- Dental Zirconia Ceramics EUDAMED
- Model / Reference
- ST-PLUS-20 EUDAMED06979063053749 EUDAMEDDHT-10 EUDAMED06975168472010 EUDAMEDDUT-25 EUDAMED06975168471082 EUDAMEDST-PLUS-12 EUDAMED06979063053787 EUDAMEDDUT-14 EUDAMED06975168471037 EUDAMEDST-25 EUDAMED06979063053640 EUDAMEDDST-10 EUDAMED06975168473017 EUDAMEDUT-14 EUDAMEDDD601458410001 EUDAMEDUT-22 EUDAMED06975168474076 EUDAMEDDHT-20 EUDAMED06975168472065 EUDAMEDHT-25 EUDAMED06975168478685 EUDAMEDHT-18 EUDAMED06975168478654 EUDAMEDST-18 EUDAMED06979063053671 EUDAMEDDHT-22 EUDAMED06975168472072 EUDAMEDDUT-16 EUDAMED06975168471044 EUDAMEDUT-12 EUDAMED06975168474021 EUDAMEDST-12 EUDAMED06979063053701 EUDAMEDST-14 EUDAMED06979063053695 EUDAMEDHT-20 EUDAMED06975168478661 EUDAMED3D-PRO-14 EUDAMED06979063053855 EUDAMEDST-PLUS-18 EUDAMED06979063053756 EUDAMEDST-PLUS-22 EUDAMED06979063053732 EUDAMED3D-PRO-22 EUDAMED06979063053817 EUDAMEDDHT-18 EUDAMED06975168472058 EUDAMEDHT-14 EUDAMED06975168478630 EUDAMEDST-PLUS-14 EUDAMED06979063053770 EUDAMEDDUT-10 EUDAMED06975168471013 EUDAMEDDHT-25 EUDAMED06975168472089 EUDAMEDHT-12 EUDAMED06975168478623 EUDAMED3D-PRO-12 EUDAMED06979063053862 EUDAMED3D-PRO-10 EUDAMED06979063053879 EUDAMEDST-22 EUDAMED06979063053657 EUDAMEDUT-20 EUDAMED06975168474069 EUDAMED3D-PRO-25 EUDAMED06979063053800 EUDAMEDDUT-12 EUDAMED06975168471020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979063053749 EUDAMED06975168472010 EUDAMED06975168471082 EUDAMED06979063053787 EUDAMED06975168471037 EUDAMED06979063053640 EUDAMED06975168473017 EUDAMED06975168474038 EUDAMED06975168474076 EUDAMED06975168472065 EUDAMED06975168478685 EUDAMED06975168478654 EUDAMED06979063053671 EUDAMED06975168472072 EUDAMED06975168471044 EUDAMED06975168474021 EUDAMED06979063053701 EUDAMED06979063053695 EUDAMED06975168478661 EUDAMED06979063053855 EUDAMED06979063053756 EUDAMED06979063053732 EUDAMED06979063053817 EUDAMED06975168472058 EUDAMED06975168478630 EUDAMED06979063053770 EUDAMED06975168471013 EUDAMED06975168472089 EUDAMED06975168478623 EUDAMED06979063053862 EUDAMED06979063053879 EUDAMED06979063053657 EUDAMED06975168474069 EUDAMED06979063053800 EUDAMED06975168471020 EUDAMED
- Basic UDI-DI
- B-06979063053749 EUDAMEDB-06975168472010 EUDAMEDB-06975168471082 EUDAMEDB-06979063053787 EUDAMEDB-06975168471037 EUDAMEDB-06979063053640 EUDAMEDB-06975168473017 EUDAMEDB-06975168474038 EUDAMEDB-06975168474076 EUDAMEDB-06975168472065 EUDAMEDB-06975168478685 EUDAMEDB-06975168478654 EUDAMEDB-06979063053671 EUDAMEDB-06975168472072 EUDAMEDB-06975168471044 EUDAMEDB-06975168474021 EUDAMEDB-06979063053701 EUDAMEDB-06979063053695 EUDAMEDB-06975168478661 EUDAMEDB-06979063053855 EUDAMEDB-06979063053756 EUDAMEDB-06979063053732 EUDAMEDB-06979063053817 EUDAMEDB-06975168472058 EUDAMEDB-06975168478630 EUDAMEDB-06979063053770 EUDAMEDB-06975168471013 EUDAMEDB-06975168472089 EUDAMEDB-06975168478623 EUDAMEDB-06979063053862 EUDAMEDB-06979063053879 EUDAMEDB-06979063053657 EUDAMEDB-06975168474069 EUDAMEDB-06979063053800 EUDAMEDB-06975168471020 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMEDQ010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental appliance fabrication material, ceramic
Dental Zirconia Ceramics by Audental Bio-Material Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06979063053749 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Audental Bio-Material Co., Ltd.
- EUDAMED SRN
- CN-MF-000023257
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (35)
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