Clearance Summary
NIL received FDA 510(k) clearance under submission number K935687, sponsored by Dentalsafe Systems Pty., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1994-02-03.
- Submission: K935687
- Applicant / Sponsor: Dentalsafe Systems Pty., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1994-02-03
Classification & Regulation
This clearance is catalogued under FDA product code EAX and 21 CFR 872.4565, within the Dental review panel as a Class I device.