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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K902158
Device Name TITANIUM/STAINLESS STEEL DENTAL IMPLANT DRILL COMP
Applicant
Impla-Med
13794 NW 4th. St.,
Suite 209
Sunrise,  FL  33325
Applicant Contact SMOLOWITZ
Correspondent
Impla-Med
13794 NW 4th. St.,
Suite 209
Sunrise,  FL  33325
Correspondent Contact SMOLOWITZ
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/15/1990
Decision Date 08/09/1990
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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