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510(k) K850927

Device
COMPLETE DENTURE REPAIR KIT
Applicant
TOOTH AID LAB, INC.
510(k) number
K850927
Product code
EBO  
Decision
Substantially Equivalent (SESE)
Decision date
1985-07-02
Date received
1985-03-05
Regulation
872.3570
Classification name
Denture Repair Kit
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
NORMAN DEAN
Address
4737 E. Holland Fresno CA US 93726 93726

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EBO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K844480DENTAL ORAL CARE SYSTEMS & COMPONENTSAdvanced Bio Systems, Inc.1985-06-19
K833056UNIVERSAL LINE-A-PLATELaurentian Laboratories1984-02-27
K833057UNIVERSAL FIX-A-PLATELaurentian Laboratories1984-02-27
K820245SAFE TDENTProfessional Dental Studios1982-04-09
K820685DENTURE ADJUSTMENT KITCamdent Laboratories1982-04-09
K770091EMERGENCY FAST-FIX DENTURE REPAIR KITMr. Clarence Hurst1977-01-24

Legacy Summary#

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FDA Review#

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