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510(k) K930151

Device
Omni-matrix
Applicant
INNOVATIVE TECHNOLOGY LTD.
510(k) number
K930151
Product code
JEP
Decision
Substantially Equivalent (SESE)
Decision date
1993-09-23
Date received
1993-01-12
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
VOLKER STEIN
Address
227 Eagle St. Newmarket Ontario L3y 1j8 CA

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
K091533SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200Garrison Dental Solutions2009-08-17
K831136DOUBLE BOW TOOTH SEPARATORAlmore Intl., Inc.1983-06-08