Clearance Summary
PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 received FDA 510(k) clearance under submission number K100854, sponsored by Premium Plus International Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2010-12-09.
- Submission: K100854
- Applicant / Sponsor: Premium Plus International Limited
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2010-12-09
Classification & Regulation
This clearance is catalogued under FDA product code EGS and 21 CFR 872.4200, within the Dental review panel as a Class I device.