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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 K980616
Device Name PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15)
Applicant
Kohler Medizintechnik GmbH & Co. KG
Danningen 9
Neuhausen,  DE D-78579
Applicant Contact DAGMAR S MASER
Correspondent
Kohler Medizintechnik GmbH & Co. KG
Danningen 9
Neuhausen,  DE D-78579
Correspondent Contact DAGMAR S MASER
Regulation Number872.3760
Classification Product Code
EBI  
Date Received02/18/1998
Decision Date 04/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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