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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 K946198
Device Name IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTOR
Applicant
Sterngold
13794 NW 4th. St.,
Suite 209
Sunrise,  FL  33325
Applicant Contact CHAD J PATTERSON
Correspondent
Sterngold
13794 NW 4th. St.,
Suite 209
Sunrise,  FL  33325
Correspondent Contact CHAD J PATTERSON
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/20/1994
Decision Date 06/14/1995
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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