DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980

Powered Laser Surgical Instrument

HOYA CONBIO, INC

The following data is part of a premarket notification filed by Hoya Conbio, Inc with the FDA for Diodent Micro Dental Laser System, Models 810 And 980.

Pre-market Notification Details

Device IDK063384
510k NumberK063384
Device Name:DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980
ClassificationPowered Laser Surgical Instrument
Applicant HOYA CONBIO, INC 19722 WESTVIEW DRIVE Twain Harte,  CA  95383
ContactLiza Burns
CorrespondentLiza Burns
HOYA CONBIO, INC 19722 WESTVIEW DRIVE Twain Harte,  CA  95383
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-11-08
Decision Date2007-03-16
Summary:summary

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