KeyPrint KeySplint Soft

Mouthguard, Prescription

Keystone Industries

The following data is part of a premarket notification filed by Keystone Industries with the FDA for Keyprint Keysplint Soft.

Pre-market Notification Details

Device IDK183598
501k NumberK183598
Device Name:KeyPrint KeySplint Soft
ClassificationMouthguard, Prescription
Applicant Keystone Industries 480 S. Democrat Rd Gibbstown,  NJ  08027
ContactNegar Movahed
CorrespondentNegar Movahed
Keystone Industries 480 S. Democrat Rd Gibbstown,  NJ  08027
Product CodeMQC  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical Specialty510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
501k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-26
Decision Date2019-11-15

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