510(k) clearance
Zirconia Dental Ceramics and Staining Solution
- 510(k) number
- K262756
- Applicant
- Fanen New Materials Technology (Suzhou) Co., Ltd.
- Decision date
- Oct 29, 2026
- Date received
- Aug 3, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- EIH
- Device type
- Powder, Porcelain
- Device class
- Class II
- Regulation
- 21 CFR 872.6660
- Advisory committee
- Dental
- Statement or summary
- Summary
- Third party
- N
- Location
- Suzhou, CN