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510(k) K844480

Device
DENTAL ORAL CARE SYSTEMS & COMPONENTS
Applicant
ADVANCED BIO SYSTEMS, INC.
510(k) number
K844480
Product code
EBO  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1985-06-19
Date received
1984-11-19
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
TRACEY PRAT
Address
80 E. Hawthorne Ave. Valley Stream NY US 11580 11580

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
K850927COMPLETE DENTURE REPAIR KITTooth Aid Lab, Inc.1985-07-02
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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