Incoris Zi
by SIRONA Dental Systems GmbH 2 variants
510(k) K062509
Incoris Zi is a Class II device made by SIRONA Dental Systems GmbH, cleared under FDA 510(k) K062509 on 12 Sep 2006, 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 | NumberK062509 | Date12 Sep 2006 | StatusActive |
Official records
- FDA 510(k) database K062509
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- Withdrawn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
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