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Glass Ceramic

by Shenzhen Xiangtong Co., Ltd. 50 variants

Part of a family of 66 devices: see the family page

Ref Hot press 0M2

Glass Ceramic (Hot press 0M2) is a device classified as Class IIa in the EU and Class II in the US made by Shenzhen Xiangtong Co., Ltd., registered in EUDAMED on 7 May 2026 (Basic UDI-DI 69423772C860P1S9L), cleared under FDA 510(k) K252789 on 8 Dec 2025 and listed in FDA GUDID since 15 Jan 2026 (UDI-DI 06942377245940), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K252789

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69423772C860P1S9L Basic UDI-DI 06942377245940UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06942377245940 UDI-DI Date15 Jan 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK252789 Date8 Dec 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69423772C860P1S9L registered 7 May 2026 Active
  • FDA 510(k) K252789 decided 8 Dec 2025 Active
  • FDA GUDID UDI-DI 06942377245940 listed 15 Jan 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K252789
  2. Listed FDA GUDID 06942377245940
  3. Registered EUDAMED 69423772C860P1S9L

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Dental appliance fabrication material, ceramic
Model / reference
Hot press 0M2
Primary DI / UDI-DI
06942377245940 EUDAMED
06942340635730 GUDID
Basic UDI-DI
69423772C860P1S9L
510(k) Number
FDA product code
EIH
EMDN code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN term
Dental appliance fabrication material, ceramic
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.6660
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06942377245940
GUDID
06942340635730
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

The registries describe this device under different primary UDI-DIs (EUDAMED lists 06942377245940; FDA GUDID lists 06942340635730), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
CN-MF-000003922
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Similar devices in this category

Other devices filed under MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER.

Other devices from Shenzhen Xiangtong Co., Ltd.

See all devices from Shenzhen Xiangtong Co., Ltd. →

Properties

  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)