FDA.reportPublic FDA data

510(k) K091533

Device
SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200
Applicant
Garrison Dental Solutions
510(k) number
K091533
Product code
JEP
Decision
Substantially Equivalent (SESE)
Decision date
2009-08-17
Date received
2009-05-26
Regulation
872.4565
Classification name
Retainer, Matrix
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOSEPH AZARY
Address
80 Shelton Technology Center Shelton CT US 06484 06484

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JEP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K930151OMNI-MATRIXInnovative Technology , Ltd.1993-09-23
K831136DOUBLE BOW TOOTH SEPARATORAlmore Intl., Inc.1983-06-08