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FDA 510(k)

KeyPrint KeySplint Hard

K-Number: K203000 · 2021-04-09

ApplicantMycone Dental Supply Co. Inc. (Dba Keystone Industries)
Decision Date2021-04-09
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

KeyPrint KeySplint Hard is the device name listed in this FDA 510(k) record. The listed applicant is Mycone Dental Supply Co. Inc. (Dba Keystone Industries). It received FDA 510(k) clearance on 2021-04-09 under 510(k) number K203000. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KeyPrint KeySplint Hard?

KeyPrint KeySplint Hard is a medical device that received FDA 510(k) clearance on 2021-04-09. The listed applicant is Mycone Dental Supply Co. Inc. (Dba Keystone Industries). The 510(k) number is K203000.

When did KeyPrint KeySplint Hard receive FDA 510(k) clearance?

KeyPrint KeySplint Hard received FDA 510(k) clearance on 2021-04-09, under 510(k) number K203000.

Who is the listed applicant for KeyPrint KeySplint Hard?

The FDA 510(k) record lists Mycone Dental Supply Co. Inc. (Dba Keystone Industries) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KeyPrint KeySplint Hard?

The FDA product code for KeyPrint KeySplint Hard is MQC.

Related Devices (Code: MQC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.K250743Remvia NightGuardRemviaK251252NOBILCAM IMPAK DiscShandong Huge Dental Material CorporationK241729Hard Splint & Thermo-Adaptive SplintWhip Mix CorporationK243516Remi Custom Night GuardGrindguard, Inc.K241369LIJIA Night GuardLijia, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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