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KeyPrint KeySplint Hard

by Mycone Dental Supply Co. Inc. (Dba Keystone Industries)

510(k) K203000

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K203000↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK203000 Date9 Apr 2021ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0630-2024 FDA Class II initiated 20 Nov 2023

    Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use (IFU).

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
MQC
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

Other devices from Mycone Dental Supply Co., T/A Keystone Industries

  • ClearMet

    Class II