510(k) K091533
K091533 is an FDA 510(k) premarket notification submitted by Garrison Dental Solutions for the device "SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200". The FDA issued a decision of Substantially Equivalent on August 17, 2009. The device falls under product code JEP (Retainer, Matrix), a Class I device regulated under 21 CFR 872.4565. Garrison Dental Solutions has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 2009
- Date Received
- May 26, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retainer, Matrix
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type