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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K082591
Device Name FLEXITIME BITE
Applicant
Heraeus Kulzer, Inc., Dental Products Division
4315 S Lafayette Blvd.
South Bend,  IN  46614
Applicant Contact CHERYL V ZIMMERMAN
Correspondent
Heraeus Kulzer, Inc., Dental Products Division
4315 S Lafayette Blvd.
South Bend,  IN  46614
Correspondent Contact CHERYL V ZIMMERMAN
Regulation Number872.3660
Classification Product Code
ELW  
Date Received09/08/2008
Decision Date 12/05/2008
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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