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Ambar Universal APS 5mL

by Dentscare Ltda

Ref 4000019361

Ambar Universal APS 5mL (4000019361) is a device classified as Class IIa in the EU and Class II in the US made by Dentscare Ltda, registered in EUDAMED on 24 Jun 2026 (Basic UDI-DI 78996338ADS003VQ) and listed in FDA GUDID since 31 Jan 2020 (UDI-DI 07899633815944), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number78996338ADS003VQ Basic UDI-DI 07899633815944UDI-DIDate24 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899633815944 UDI-DI Date31 Jan 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 78996338ADS003VQ registered 24 Jun 2026 Active
  • FDA GUDID UDI-DI 07899633815944 listed 31 Jan 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07899633815944
  2. Registered EUDAMED 78996338ADS003VQ

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  • Withdrawn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
Ambar Universal APS 5mL EUDAMED
Ambar Universal APS GUDID
Generic name
Dentine bonding agent/set
Model / Ref / Catalog
4000019361, 5mL
Primary DI / UDI-DI
07899633815944
Basic UDI-DI
78996338ADS003VQ
FDA product code
KLE
EMDN code
Q01010104 Dental bonding agents
GMDN term
Dentine bonding agent/set
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3200
EU registration type
Standard device
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
4000019361
GUDID
5mL
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: Dentine bonding agent/set

Similar devices in this category

Other devices filed under DENTAL BONDING AGENTS.

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Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)