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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Toothbrush, Manual
510(k) Number K771184
Device Name TOOTHBRUSH, ORTHODONTIC, #0126-0189-00
Applicant
Hoyt Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Hoyt Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.6855
Classification Product Code
EFW  
Date Received06/29/1977
Decision Date 07/15/1977
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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