FDA.reportPublic FDA data

510(k) K232087

Device
Dental LT Comfort Resin
Applicant
Formlabs Ohio, Inc.
510(k) number
K232087
Product code
MQC
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-16
Date received
2023-07-13
Classification name
Mouthguard, Prescription
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ritika Sharma
Address
27800 Lemoyne Rd. Millbury OH US 43447 43447

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MQC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.2026-03-02
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K251252NOBILCAM IMPAK DiscShandong Huge Dental Material Corporation2025-08-01
K241729Hard Splint & Thermo-Adaptive SplintWhip Mix Corporation2025-03-18
K243516Remi Custom Night GuardGrindguard, Inc.2025-02-10
K241369LIJIA Night GuardLijia, LLC2024-08-22
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K241311Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)Bernhard Förster GmbH2024-08-02
K240463Slow Wave DS8 (SWDS802)Slow Wave, Inc.2024-06-04
K231793RODIN 3D Resin SPLINT, Hard/FlexBelport Company, Inc., Gingi-Pak2024-03-26
K230548Myoaligner ApplianceMyohealth Technologies, LLC2024-02-02
K230592LuxCreo Dental Night Guard ResinLuxCreo, Inc.2024-01-18
K222845Clench Relief Mouth Piece PRO RX, Clench Relief Mouth PieceFrey Oral Technologies, LLC2023-11-28
K230495Serena Sleep Night GuardMeris Investment Group2023-10-13
K232448FREEPRINT® splintmasterDetax GmbH2023-10-12