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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K991946
Device Name ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L
Applicant
Sterilex Corp.
7-I Gwynns Hill Ct.
Owins Mills,  MD  21117
Applicant Contact SHIRA KRAMER
Correspondent
Sterilex Corp.
7-I Gwynns Hill Ct.
Owins Mills,  MD  21117
Correspondent Contact SHIRA KRAMER
Regulation Number872.6640
Classification Product Code
EIA  
Date Received06/09/1999
Decision Date 09/03/1999
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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