Incoris Zi
by SIRONA Dental Systems GmbH 2 variants
510(k) K123664
Incoris Zi is a Class II device made by SIRONA Dental Systems GmbH, cleared under FDA 510(k) K123664 on 8 Apr 2013, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK123664 | Date8 Apr 2013 | StatusActive |
Official records
- FDA 510(k) database K123664
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EIH
- Device class
- Class II
- Regulation
- 21 CFR Part 872.6660
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code EIH (Powder, Porcelain).
- Amber® LiSi-POZ Amber LiSi-POZ LT R15/D3 by Hass Corporation
- Amber® Press Amber Press HT R7/B4 by Hass Corporation
- SHOFU PORCELAIN STAIN by SHOFU DENTAL CORP.
- CERAMIX PORCELAIN SYSTEM by C-Mix
- DLMS-ZIRBLOCKS by Dental Milling Laboratory Supplies (Dlms)
- K2 Li-Enamel, E-58, 20g. 3873002 by Yeti Dentalprodukte GmbH
- Ceramco® 3 Dentin C3 301149 by Dentsply International
- Celtra Ceram 650135 by Dentsply International
- IPS INLINE POM SYSTEM by Ivoclar Vivadent, Inc.
- VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, by Vident