Clearance Summary
DENTAL AIR BRUSH received FDA 510(k) clearance under submission number K780460, sponsored by M. Joel Gebhart, D.D.S.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1978-06-28.
- Submission: K780460
- Applicant / Sponsor: M. Joel Gebhart, D.D.S.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4520
- Decision date: 1978-06-28
Classification & Regulation
This clearance is catalogued under FDA product code KOH and 21 CFR 884.4520, within the Obstetrics/Gynecology review panel as a Class I device.