Clearance Summary
TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID received FDA 510(k) clearance under submission number K131068, sponsored by Kuraray Noritake Dental, 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 2013-08-27.
- Submission: K131068
- Applicant / Sponsor: Kuraray Noritake Dental, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3250
- Decision date: 2013-08-27
Classification & Regulation
This clearance is catalogued under FDA product code EJK and 21 CFR 872.3250, within the Dental review panel as a Class II device.