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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 K934126
Device Name ONE AND TWO PIECE TEMPORARY HEALING,(EMERGENCE PROFILE) ABUTMENTS
Applicant
IMPLANT INNOVATIONS, INC.
3071 CONTINENTAL DR.
WEST PALM BEACH,  FL  33407
Applicant Contact WILLIAM G CONETY
Correspondent
IMPLANT INNOVATIONS, INC.
3071 CONTINENTAL DR.
WEST PALM BEACH,  FL  33407
Correspondent Contact WILLIAM G CONETY
Regulation Number872.3640
Classification Product Code
DZE  
Date Received08/25/1993
Decision Date 04/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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