Clearance Summary
PERFECT TISSUE CONTOURING SYSTEM II received FDA 510(k) clearance under submission number K071632, sponsored by Coltene/Whaledent, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2007-10-18.
- Submission: K071632
- Applicant / Sponsor: Coltene/Whaledent, Inc.
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4920
- Decision date: 2007-10-18
Classification & Regulation
This clearance is catalogued under FDA product code EKZ and 21 CFR 872.4920, within the Dental review panel as a Class II device.