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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 K852305
Device Name FLEXIROOT
Applicant
Facial Alveodental Implant Rehabilitation, Inc.
1617 Broadway, Suite 10
Vallejo,  CA  96590
Applicant Contact PETER G MOZSARY
Correspondent
Facial Alveodental Implant Rehabilitation, Inc.
1617 Broadway, Suite 10
Vallejo,  CA  96590
Correspondent Contact PETER G MOZSARY
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/29/1985
Decision Date 10/16/1985
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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