Skip to content

SMARTDent 3.1.0.0

by Ray Co., Ltd

Ref RBS-SD01Model SMARTDent

SMARTDent 3.1.0.0 is a dental treatment application software (EU MDD Class IIa; FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Ray Co., Ltd, registered in EUDAMED on 19 Oct 2026 (Basic UDI-DI B-08800003005017), cleared under FDA 510(k) K251109 on 21 May 2025 and listed in FDA GUDID since 28 May 2025 (UDI-DI 08800003005017), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K251109

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800003005017 Basic UDI-DI 08800003005017UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800003005017 UDI-DI Date28 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK251109 Date21 May 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800003005017 registered 19 Oct 2026 Active
  • FDA 510(k) K251109 decided 21 May 2025 Active
  • FDA GUDID UDI-DI 08800003005017 listed 28 May 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K251109
  2. Listed FDA GUDID 08800003005017
  3. Registered EUDAMED B-08800003005017

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
SMARTDent
Generic name
Dental treatment application software
Model / reference
SMARTDent EUDAMED
RBS-SD01 EUDAMED
3.1.0.0 GUDID
Primary DI / UDI-DI
08800003005017
Basic UDI-DI
B-08800003005017
510(k) Number
FDA product code
LLZ
EMDN code
Z11030392 Instruments for extraoral dental radiology - medical device software
GMDN term
Dental treatment application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
SMARTDent
RBS-SD01
GUDID
3.1.0.0
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 treatment application software

Similar devices in this category

Other devices filed under INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY - MEDICAL DEVICE SOFTWARE.

Other devices from Ray Co., Ltd

See all devices from Ray Co., Ltd →

Properties

  • Measuring function
  • Lot / batch number
Other properties (21, all answered No)