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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name adhesive, bracket and tooth conditioner, resin
510(k) Number K020648
Device Name GRIDLOCK 195 ADHESIVE
Applicant
ALLODEX SYSTEMS
10195 EAST WETHERSFIELD RD.
SCOTTSDALE,  AZ  85260
Applicant Contact MELVYN A STEINBERG
Correspondent
ALLODEX SYSTEMS
10195 EAST WETHERSFIELD RD.
SCOTTSDALE,  AZ  85260
Correspondent Contact MELVYN A STEINBERG
Regulation Number872.3750
Classification Product Code
DYH  
Date Received02/28/2002
Decision Date 05/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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