Shade Plus DSDZ22
Part of a family of 80 devices: see the family page
Ref DSDZ22
Shade Plus DSDZ22 is a Class IIa device made by DMAX Co., Ltd., registered in EUDAMED on 30 Mar 2022 (Basic UDI-DI 88001552SP00ML) with CE/MDR certificate KR26/00000032 valid until 4 Mar 2031, active as of 22 Oct 2026.
Active
CE MDR
Valid until
4 Mar 2031
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberKR26/00000032 | Date4 Mar 2026 | StatusActive |
Official records
- EUDAMED public site 88001552SP00ML
Certificates
- KR26/00000032 Active
Quality management system EU MDR
- Certifier
- SGS Belgium NV 1639
- Issued
- 4 Mar 2026
- Expires
- 4 Mar 2031
Timeline
- Registered EUDAMED 88001552SP00ML
- Certificate issued EUDAMED KR26/00000032
- Certificate expires EUDAMED KR26/00000032
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Dental ceramic block for artificial tooth prostheses
- Model / reference
- DSDZ22
- Primary DI / UDI-DI
- 08800155211472
- Basic UDI-DI
- 88001552SP00ML
- EMDN code
- Q010699 Materials for the preparation of custom-made dental devices - other
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- KR-MF-000020635
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Similar devices in this category
Other devices filed under MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER.
- Amber® LiSi-POM Amber LiSi-POM LT R10/D2 by Hass Corporation
- Dental Zirconia Block 16187 by SHENZHEN YURUCHENG DENTAL MATERIALS CO., LTD.
- Dental Sheet YQ-B by Sichuan Yaqi Medical Technology Co., Ltd.
- Duraliner II Duraliner II Package by Reliance Dental Manufacturing
- Additive Manufacturing (Light Curing) Crown Bridge Resin Monochromatic-500g by Aidite (Qinhuangdao) Technology Co., Ltd.
- Amber® LiSi-POZ Amber LiSi-POZ LT R7/A3 by Hass Corporation