3M ESPE LAVA CHAIRSIDE ORAL SCANNER

System, Optical Impression, Computer Assisted Design And Manufacturing (cad/cam) Of Dental Restorations

BRONTES TECHNOLOGIES

The following data is part of a premarket notification filed by Brontes Technologies with the FDA for 3m Espe Lava Chairside Oral Scanner.

Pre-market Notification Details

Device IDK073199
510k NumberK073199
Device Name:3M ESPE LAVA CHAIRSIDE ORAL SCANNER
ClassificationSystem, Optical Impression, Computer Assisted Design And Manufacturing (cad/cam) Of Dental Restorations
Applicant BRONTES TECHNOLOGIES 20310 SW 48TH ST. Southwest Ranches,  FL  33332
ContactJohn Greenbaum
CorrespondentJohn Greenbaum
BRONTES TECHNOLOGIES 20310 SW 48TH ST. Southwest Ranches,  FL  33332
Product CodeNOF  
CFR Regulation Number872.3661 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-13
Decision Date2007-12-21
Summary:summary

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