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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 K945847
Device Name FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE
Applicant
Friatec Medical Inc., USA
9229 Cranford Dr.
Potomac,  MD  20854
Applicant Contact ROBERT J SLOMOFF
Correspondent
Friatec Medical Inc., USA
9229 Cranford Dr.
Potomac,  MD  20854
Correspondent Contact ROBERT J SLOMOFF
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/30/1994
Decision Date 03/15/1996
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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