510(k) clearance
INNI-CERA (BCM-W500, BCM-W1000)
- 510(k) number
- K262980
- Applicant
- DentMedi Co., Ltd.
- Decision date
- Oct 21, 2026
- Date received
- Aug 27, 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
- Gunposi, KR