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
510k 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-26
Decision Date2019-11-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H66842201551 K183598 000
H66842200051 K183598 000
H66842001551 K183598 000
H66842000051 K183598 000
D040711861 K183598 000
00810002220173 K183598 000

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