Skip to content

Dentra III 5944830

by Carestream Dental LLC

Part of a family of 10 devices: see the family pagePart of a family of 23 devices: see the family page

Ref 5944830Model 6200

Dentra III 5944830 is a device classified as Class IIa in the EU and Class II in the US made by Carestream Dental LLC, registered in EUDAMED on 13 Oct 2022 (Basic UDI-DI 0192155RVG9XP) and listed in FDA GUDID since 2 Jun 2023 (UDI-DI 60192155944833), 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
United StatesGUDID listing GUDID Number60192155944833 UDI-DI Date2 Jun 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0192155RVG9XP Basic UDI-DI Date13 Oct 2022RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0192155RVG9XP registered 13 Oct 2022 Active
  • FDA GUDID UDI-DI 60192155944833 listed 2 Jun 2023 Listed

Timeline

2 dated events

  1. Registered EUDAMED 0192155RVG9XP
  2. Listed FDA GUDID 60192155944833

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  • Withdrawn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
Dentra III
Generic name
Dental digital imaging sensor, intraoral
Device name
Rvg 6200
6200
Model / Ref / Catalog
5944830, 6200
Primary DI / UDI-DI
60192155944833, 60192155950483
Basic UDI-DI
0192155RVG9XP, 0192155RVG9SYSX2
FDA product code
EAP
EMDN code
Z11030402 Systems for intraoral digital videoradiography
GMDN term
Dental digital imaging sensor, intraoral
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.1810
System or procedure pack
System
EU registration type
Standard device
System or procedure pack
EU market of registration
France
Medical purpose
The RVG 142, RVG 5200, RVG 6200, RVG Optima and DENTRA lll digital intra-oral X-ray sensors are intended to produce an image of the dental area at the direction of dentists, oral surgeons and orthodontists for X-ray imaging of the dento-maxillofacial area for pediatric and adult patients
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Dental digital imaging sensor, intraoral

Similar devices in this category

Other devices filed under SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY.

Other devices from Carestream Dental LLC

See all devices from Carestream Dental LLC →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)