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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Dental, Intraoral
510(k) Number K914724
Device Name ADA SHANK EXTENSION
Applicant
Implant Corp. of America
2299 9th Ave. N., Suite 1-E
St. Petersburg,  FL  33713
Applicant Contact O.HILT TATUM
Correspondent
Implant Corp. of America
2299 9th Ave. N., Suite 1-E
St. Petersburg,  FL  33713
Correspondent Contact O.HILT TATUM
Regulation Number872.4130
Classification Product Code
DZA  
Date Received10/18/1991
Decision Date 07/27/1993
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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