FDA 510(k)

KeyPrint KeySplint Soft

K-Number: K183598 · 2019-11-15

Decision Date2019-11-15

Product CodeMQC

DecisionSubstantially Equivalent

Device Summary

KeyPrint KeySplint Soft is the device name listed in this FDA 510(k) record. The listed applicant is Keystone Industries. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K183598. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KeyPrint KeySplint Soft?

KeyPrint KeySplint Soft is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Keystone Industries. The 510(k) number is K183598.

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

KeyPrint KeySplint Soft received FDA 510(k) clearance on 2019-11-15, under 510(k) number K183598.

Who is the listed applicant for KeyPrint KeySplint Soft?

The FDA 510(k) record lists Keystone Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KeyPrint KeySplint Soft?

The FDA product code for KeyPrint KeySplint Soft is MQC.

Other records listing Keystone Industries as applicant

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.

K250489FP3D K241089KeyPrint KeyDenture Base

Related Devices (Code: MQC)

K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.K250743Remvia NightGuardRemvia K251252NOBILCAM IMPAK DiscShandong Huge Dental Material Corporation K241729Hard Splint & Thermo-Adaptive SplintWhip Mix Corporation K243516Remi Custom Night GuardGrindguard, Inc.K241369LIJIA Night GuardLijia, LLC

Official Source

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