FDA.reportPublic FDA data

510(k) K890355

Device
DENTAL X-RAY BITE BLOCK
Applicant
BITE-A-BLOCK
510(k) number
K890355
Product code
EGZ  
Decision
Substantially Equivalent (SESE)
Decision date
1989-06-12
Date received
1989-01-24
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#

Contact
NANCY T PUA
Address
P.O. Box 810 Daly City CA US 94017 94017

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
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
K801079KWIX-BITE X-RAY FILM HOLDERHenry Schein, Inc.1980-05-20

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases