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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Endodontic Stabilizing
510(k) Number K972985
Device Name SPLINT IT
Applicant
Jeneric/Pentron, Inc.
53 N. Plains Industrial Rd.
P.O. Box 724
Wallingford,  CT  06492
Applicant Contact MURRAY G GAMBERG
Correspondent
Jeneric/Pentron, Inc.
53 N. Plains Industrial Rd.
P.O. Box 724
Wallingford,  CT  06492
Correspondent Contact MURRAY G GAMBERG
Regulation Number872.3890
Classification Product Code
ELS  
Date Received08/11/1997
Decision Date 09/24/1997
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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