510(k) clearance
Dr.AlignNavi
- 510(k) number
- K262378
- Applicant
- InnoDtech, Inc.
- Decision date
- Oct 7, 2026
- Date received
- Jul 13, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PNN
- Device type
- Orthodontic Software
- Device class
- Class II
- Regulation
- 21 CFR 872.5470
- Advisory committee
- Dental
- Statement or summary
- Summary
- Third party
- N
- Location
- Gwangju, KR