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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name laser, fluorescence caries detection
De Novo Number DEN990002
510(K) Number K983658
Device Name KAVO DIAGNODENT
Requester
kavo america
340 east main st.
lake zurich,  IL  60047
Contact douglas cochrane
Regulation Number872.1745
Classification Product Code
NBL  
Date Received07/12/1999
Decision Date 02/22/2000
Decision granted (DENG)
Classification Advisory Committee Dental
Review Advisory Committee Dental
Classification Order Classification Order
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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