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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bur, Dental
510(k) Number K071352
Device Name CERADRILL
Applicant
Gebr. Brasseler GmbH & Co. KG
Trophagener Weg 25
Lemgo,  DE D-32657
Applicant Contact OLAF BRAND
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number872.3240
Classification Product Code
EJL  
Date Received05/15/2007
Decision Date 06/29/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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