OPTIMA MX

Unit, Operative Dental

BIEN-AIR SA SWITZERLAND

The following data is part of a premarket notification filed by Bien-air Sa Switzerland with the FDA for Optima Mx.

Pre-market Notification Details

Device IDK042759
510k NumberK042759
Device Name:OPTIMA MX
ClassificationUnit, Operative Dental
Applicant BIEN-AIR SA SWITZERLAND LANGASSE 60, CASE POSTALE Bienne 6,  CH Ch-2500
ContactAlain Leonetti
CorrespondentErin Sparnon
CITECH 5200 BUTLER PIKE Plymouth Meeting,  PA  19462 -1298
Product CodeEIA  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2004-10-05
Decision Date2004-10-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D9501318601 K042759 000
D9501318500 K042759 000
D9501317701 K042759 000

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