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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Periodontic, Endodontic, Irrigating
510(k) Number K861846
Device Name HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT
Applicant
Solar Dental Co., Inc.
111n. Wabash
Chicago,  IL  60602
Applicant Contact BAUER, PHD
Correspondent
Solar Dental Co., Inc.
111n. Wabash
Chicago,  IL  60602
Correspondent Contact BAUER, PHD
Regulation Number872.4565
Classification Product Code
EIC  
Date Received05/13/1986
Decision Date 06/26/1986
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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