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510(k) K831136

Device
DOUBLE BOW TOOTH SEPARATOR
Applicant
ALMORE INTL., INC.
510(k) number
K831136
Product code
JEP  
Decision
Substantially Equivalent (SESE)
Decision date
1983-06-08
Date received
1983-04-07
Regulation
872.4565
Classification name
Retainer, Matrix
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K930151OMNI-MATRIXInnovative Technology , Ltd.1993-09-23

Legacy Summary#

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FDA Review#

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