K251597
- 510(k) number
- K251597
- Device name
- InnerView System
- Applicant
- Perimetrics, Inc. WA · US
- Product code
- EKX — Handpiece, Direct Drive, Ac-Powered
- Decision date
- 2025-09-18
- Date received
- 2025-05-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K251597.pdf
Official FDA record: K251597
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.