Clearance Summary
SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200 received FDA 510(k) clearance under submission number K091533, sponsored by Garrison Dental Solutions. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-08-17.
- Submission: K091533
- Applicant / Sponsor: Garrison Dental Solutions
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 2009-08-17
Classification & Regulation
This clearance is catalogued under FDA product code JEP and 21 CFR 872.4565, within the Dental review panel as a Class I device.