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510(k) K801079

Device
KWIX-BITE X-RAY FILM HOLDER
Applicant
HENRY SCHEIN, INC.
510(k) number
K801079
Product code
EGZ  
Decision
Substantially Equivalent (SESE)
Decision date
1980-05-20
Date received
1980-05-07
Regulation
872.1905
Classification name
Holder, Film, X-ray
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 EGZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K913160ID-TABNix Co. , Ltd.1991-09-06
K913168SALIBAGNix Co. , Ltd.1991-09-06
K890355DENTAL X-RAY BITE BLOCKBite-A-Block1989-06-12
K853451TROLL-BITETrollplast, Inc.1986-01-21
K852170EZX YELLOW, BLUE OR ORANGEStrong Marketing1985-09-05
K853005S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARMThe S. S. White Co.1985-08-13
K813378UNI-BITE DENTAL X-RAY FILM HOLDERRinn Corp.1982-01-29

Legacy Summary#

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FDA Review#

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