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TPH Spectra ST 642016

by Dentsply De Trey GmbH

Part of a family of 118 devices: see the family page

Ref 642016

TPH Spectra ST 642016 is a device classified as Class IIa in the EU and Class II in the US made by Dentsply De Trey GmbH, registered in EUDAMED on 23 Sep 2026 (Basic UDI-DI ++D010FIM03R3) and listed in FDA GUDID since 11 Dec 2025 (UDI-DI D0106420161), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++D010FIM03R3 Basic UDI-DI D0106420161UDI-DIDate23 Sep 2026RegisteredStatusActive EUDAMED: not on the EU market
United StatesGUDID listing GUDID NumberD0106420161 UDI-DI Date11 Dec 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++D010FIM03R3 registered 23 Sep 2026 Active
  • FDA GUDID UDI-DI D0106420161 listed 11 Dec 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D0106420161
  2. Registered EUDAMED ++D010FIM03R3

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
TPH Spectra ST Universal Composite Restorative Sample Kit EUDAMED
TPH Spectra ST GUDID
Generic name
Dental composite resin
Device name
Ceram.x Spectra ST, TPH Spectra ST, Neo Spectra ST
Model / Ref / Catalog
642016
Primary DI / UDI-DI
D0106420161
Basic UDI-DI
++D010FIM03R3
FDA product code
EBF
EMDN code
Q01010103 Dental restorative composites
GMDN term
Dental composite resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3690
EU registration type
Standard device
GUDID distribution status
In Commercial Distribution
Size
Weight — 0.25 Gram

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

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.

Similar devices in this category

Other devices filed under DENTAL RESTORATIVE COMPOSITES.

Other devices from Dentsply De Trey GmbH

See all devices from Dentsply De Trey GmbH →

Properties

  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)