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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 K142846
Device Name BBX1, BBX2, BBX1MO, BBX1MC
Applicant
Globaldental, Inc.
San Antonio Drama St. #2067
Ponce,  PR  00728
Applicant Contact EBLESS V BAEZ ALERS
Correspondent
Globaldental, Inc.
San Antonio Drama St. #2067
Ponce,  PR  00728
Correspondent Contact EBLESS V BAEZ ALERS
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received09/30/2014
Decision Date 09/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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