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Ortho Bite 4g

by Dentscare Ltda

Ref 4000019365

Ortho Bite 4g (4000019365) is a device classified as Class IIa in the EU and Class II in the US made by Dentscare Ltda, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 78996338CEM006VR) and listed in FDA GUDID since 27 Apr 2022 (UDI-DI 07899633815982), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number78996338CEM006VR Basic UDI-DI 07899633815982UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899633815982 UDI-DI Date27 Apr 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 78996338CEM006VR registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 07899633815982 listed 27 Apr 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07899633815982
  2. Registered EUDAMED 78996338CEM006VR

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  • Withdrawn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
Ortho Bite Blue EUDAMED
Ortho Bite GUDID
Generic name
Orthodontic bracket adhesive
Model / Ref / Catalog
4000019365, 4g
Primary DI / UDI-DI
07899633815982
Basic UDI-DI
78996338CEM006VR
FDA product code
EBF, DYH
EMDN code
Q010407 Orthodontic cements
GMDN term
Orthodontic bracket adhesive
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3690, 872.3750
EU registration type
Standard device
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
4000019365
GUDID
4g
Device classEUDAMED
Class IIa
GUDID
Class II

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: Orthodontic bracket adhesive

Similar devices in this category

Other devices filed under ORTHODONTIC CEMENTS.

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Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (21, all answered No)