Clearance Summary
PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M received FDA 510(k) clearance under submission number K101551, sponsored by Delma Medical Instrument (Guangzhou) Co., 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 2010-09-09.
- Submission: K101551
- Applicant / Sponsor: Delma Medical Instrument (Guangzhou) Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2010-09-09
Classification & Regulation
This clearance is catalogued under FDA product code EFB and 21 CFR 872.4200, within the Dental review panel as a Class I device.