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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Prescription
510(k) Number K222061
Device Name Dental LT Clear V2 Resin
Applicant
Formlabs Ohio, Inc.
27800 Lemoyne Rd.
Millbury,  OH  43447
Applicant Contact Ritika Sharma
Correspondent
Formlabs Ohio, Inc.
27800 Lemoyne Rd.
Millbury,  OH  43447
Correspondent Contact Ritika Sharma
Classification Product Code
MQC  
Subsequent Product Codes
DYT   KMY  
Date Received07/13/2022
Decision Date 11/10/2022
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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