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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Orthodontic
510(k) Number K923839
Device Name NITINOL GENTLE TOUCH COIL SPRING
Applicant
Ultimate Wireforms, Inc.
88 Harwinton Ave.
Terryville,  CT  06786
Applicant Contact PAUL J BLANCHETTE
Correspondent
Ultimate Wireforms, Inc.
88 Harwinton Ave.
Terryville,  CT  06786
Correspondent Contact PAUL J BLANCHETTE
Regulation Number872.5410
Classification Product Code
DZC  
Date Received07/30/1992
Decision Date 10/15/1992
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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