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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gutta-Percha
510(k) Number K863411
Device Name GUTTA PERCHA
Applicant
Endodent, Inc.
135 E. Chestnut Ave.
Suite 5, P.O. Box 1606
Monrovia,  CA  91016
Applicant Contact MAX LENZ
Correspondent
Endodent, Inc.
135 E. Chestnut Ave.
Suite 5, P.O. Box 1606
Monrovia,  CA  91016
Correspondent Contact MAX LENZ
Regulation Number872.3850
Classification Product Code
EKM  
Date Received09/03/1986
Decision Date 10/30/1986
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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