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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Agent, Polishing, Abrasive, Oral Cavity
510(k) Number K905303
Device Name ABUTMENT GLO
Applicant
Implant Innovations International, Inc.
1897 Palm Beach Lakes Blvd.
Suite 114
West Palm Beach,  FL  33409
Applicant Contact WILLIAM O CONETY
Correspondent
Implant Innovations International, Inc.
1897 Palm Beach Lakes Blvd.
Suite 114
West Palm Beach,  FL  33409
Correspondent Contact WILLIAM O CONETY
Regulation Number872.6030
Classification Product Code
EJR  
Date Received11/28/1990
Decision Date 06/10/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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