Dr.AlignNavi— 510(k) K262378
Substantially EquivalentInnoDtech, Inc.
FDA 510(k) clearance K262378 for Dr.AlignNavi, Substantially Equivalent on 2026-10-07. Applicant: InnoDtech, Inc.. Device class: 2.
Summary
Dr.AlignNavi from InnoDtech is filed under PNN, orthodontic software. The record doesn't describe its functions beyond that product code.
Class II, 21 CFR 872.5470. The Dental panel reviewed it as a Traditional 510(k).
InnoDtech filed from Gwangju, South Korea. Review took 86 days (July 13 to October 7, 2026).
Clearance details
- Applicant
- InnoDtech, Inc.
- Product code
- Product code PNN
- Device class
- Class 2
- Regulation
- 21 CFR 872.5470
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gwangju, KR
Recent devices under product code PNN
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