510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091533Substantially Equivalent

Slicks Sectional Matrix and Matrix Bands, Models Sm100, Sm150, Sm175, Sm200, Sm300, Smh100, Smh150, Smh175 and Smh200

Garrison Dental Solutions, Shelton CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091533 is the FDA 510(k) clearance record for SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200, a class I device, cleared for Garrison Dental Solutions on under FDA product code JEP (Retainer, Matrix). FDA records list 3 510(k) clearances for Garrison Dental Solutions, from to . As of , FDA records show no recalls naming K091533.

Clearance record

Decision date
Received
(83 days to decision)
Product code
JEP Retainer, Matrix
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Garrison Dental Solutions 80 Shelton Technology Center, Shelton CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JEP

Trailing 12 months

FDA records hold no clearances under product code JEP in the trailing twelve months.

FDA records show no clearances under product code JEP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JEP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260