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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 K061481
Device Name GRENGLOO
Applicant
ORMCO CORP.
100 BAYVIEW CIRCLE
SUITE 6000
NEWPORT BEACH,  CA  92660
Applicant Contact COLLEEN BOSWELL
Correspondent
ORMCO CORP.
100 BAYVIEW CIRCLE
SUITE 6000
NEWPORT BEACH,  CA  92660
Correspondent Contact COLLEEN BOSWELL
Regulation Number872.3750
Classification Product Code
DYH  
Date Received05/30/2006
Decision Date 07/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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