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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Post, Root Canal
510(k) Number K950213
Device Name THE STERN ROOT ANCHOR SYSTEM
Applicant
Sterngold/Implamed
13794 NW 4th. St.,
Suite 209
Sunrise,  FL  33325
Applicant Contact NICHOLAS SAVARESE
Correspondent
Sterngold/Implamed
13794 NW 4th. St.,
Suite 209
Sunrise,  FL  33325
Correspondent Contact NICHOLAS SAVARESE
Regulation Number872.3810
Classification Product Code
ELR  
Date Received01/19/1995
Decision Date 03/23/1995
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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