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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K073040
Device Name SMH FLEX S
Applicant
Smh Biomaterial AG
3537 Teasley Ln.
Denton,  TX  76210
Applicant Contact ASHLEY TRUITT
Correspondent
Smh Biomaterial AG
3537 Teasley Ln.
Denton,  TX  76210
Correspondent Contact ASHLEY TRUITT
Regulation Number872.3760
Classification Product Code
EBI  
Subsequent Product Code
MQC  
Date Received10/29/2007
Decision Date 12/13/2007
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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