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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 K112397
Device Name ORTHO-JET CRYSTAL
Applicant
Lang Dental Mfg. Co., Inc.
P.O Box 969
Wheeling,  IL  60090 -0969
Applicant Contact DAVID LANG
Correspondent
Lang Dental Mfg. Co., Inc.
P.O Box 969
Wheeling,  IL  60090 -0969
Correspondent Contact DAVID LANG
Regulation Number872.3760
Classification Product Code
EBI  
Date Received08/19/2011
Decision Date 11/04/2011
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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