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Reflectys A3.5 Cp

by Itena Clinical

Ref CPTYS-A3.5

Reflectys A3.5 Cp (CPTYS-A3.5) is a device classified as Class IIa in the EU and Class II in the US made by Itena Clinical, registered in EUDAMED on 2 Jul 2026 (Basic UDI-DI B-03760260220194) and listed in FDA GUDID since 15 Oct 2016 (UDI-DI 03760260220194), active as of 24 Oct 2026.

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

CE MDD

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760260220194 Basic UDI-DI 03760260220194UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760260220194 UDI-DI Date15 Oct 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03760260220194 registered 2 Jul 2026 Active
  • FDA GUDID UDI-DI 03760260220194 listed 15 Oct 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03760260220194
  2. Registered EUDAMED B-03760260220194

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Reflectys
Generic name
Dental composite resin
Model / Ref / Catalog
CPTYS-A3.5, A3.5 CP
Primary DI / UDI-DI
03760260220194
Basic UDI-DI
B-03760260220194
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
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
CPTYS-A3.5
GUDID
A3.5 CP
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.

Related devices

Category: Dental composite resin

Similar devices in this category

Other devices filed under DENTAL RESTORATIVE COMPOSITES.

Other devices from Itena Clinical

See all devices from Itena Clinical →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)