Clearance Summary
PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF received FDA 510(k) clearance under submission number K111169, sponsored by Kwang Myung Daicom, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2011-10-03.
- Submission: K111169
- Applicant / Sponsor: Kwang Myung Daicom, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5500
- Decision date: 2011-10-03
Classification & Regulation
This clearance is catalogued under FDA product code DZB and 21 CFR 872.5500, within the Dental review panel as a Class II device.