Dental LT Clear V2 Resin

Mouthguard, Prescription

Formlabs Ohio, Inc.

The following data is part of a premarket notification filed by Formlabs Ohio, Inc. with the FDA for Dental Lt Clear V2 Resin.

Pre-market Notification Details

Device IDK222061
510k NumberK222061
Device Name:Dental LT Clear V2 Resin
ClassificationMouthguard, Prescription
Applicant Formlabs Ohio, Inc. 27800 Lemoyne Rd Millbury,  OH  43447
ContactRitika Sharma
CorrespondentRitika Sharma
Formlabs Ohio, Inc. 27800 Lemoyne Rd Millbury,  OH  43447
Product CodeMQC  
Subsequent Product CodeDYT
Subsequent Product CodeKMY
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-13
Decision Date2022-11-10

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