KeyPrint KeySplint Hard

Mouthguard, Prescription

Mycone Dental Supply Co. Inc. (DBA Keystone Industries)

The following data is part of a premarket notification filed by Mycone Dental Supply Co. Inc. (dba Keystone Industries) with the FDA for Keyprint Keysplint Hard.

Pre-market Notification Details

Device IDK203000
510k NumberK203000
Device Name:KeyPrint KeySplint Hard
ClassificationMouthguard, Prescription
Applicant Mycone Dental Supply Co. Inc. (DBA Keystone Industries) 480 S. Democrat Road Gibbstown,  NJ  08027
ContactDiamond Bynum
CorrespondentDiamond Bynum
Mycone Dental Supply Co. Inc. (DBA Keystone Industries) 480 S. Democrat Road Gibbstown,  NJ  08027
Product CodeMQC  
Subsequent Product CodeEBI
Subsequent Product CodeKMY
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-01
Decision Date2021-04-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H66842200042 K203000 000
H66842000042 K203000 000

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