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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elevator, Surgical, Dental
510(k) Number K851713
Device Name 680/1 TO 785/2 VARIOUS TYPES & SIZES OF ROOT ELEVA
Applicant
Artiberia
4518 Los Ranchitos
San Antonio,  TX  78233
Applicant Contact GIL M SANCHEZ
Correspondent
Artiberia
4518 Los Ranchitos
San Antonio,  TX  78233
Correspondent Contact GIL M SANCHEZ
Regulation Number872.4565
Classification Product Code
EMJ  
Date Received04/25/1985
Decision Date 06/11/1985
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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