Stratasys TrueDent

Resin, Denture, Relining, Repairing, Rebasing

Stratasys Ltd

The following data is part of a premarket notification filed by Stratasys Ltd with the FDA for Stratasys Truedent.

Pre-market Notification Details

Device IDK220771
510k NumberK220771
Device Name:Stratasys TrueDent
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant Stratasys Ltd 1 Holtzman St. Science Park P.O. Box 2496 Rehovot,  IL 7612401
ContactMelanie Glennon
CorrespondentMelissa Burbage
PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego,  CA  92130
Product CodeEBI  
Subsequent Product CodeEBF
Subsequent Product CodeEBG
Subsequent Product CodePZY
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-16
Decision Date2022-07-07

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