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Ot Equator Smart Box Ot Equator

by Rhein 83 SRL

Ref 330SBEYModel *SMART BOX

Ot Equator Smart Box Ot Equator (330SBEY) is a device classified as Class IIa in the EU and Class I in the US made by Rhein 83 SRL, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-08059224151526) and listed in FDA GUDID since 27 Aug 2026 (UDI-DI 08059224151526), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08059224151526 Basic UDI-DI 08059224151526UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08059224151526 UDI-DI Date27 Aug 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08059224151526 registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI 08059224151526 listed 27 Aug 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08059224151526
  2. Registered EUDAMED B-08059224151526

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  • Withdrawn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
Smart Box Ot Equator EUDAMED
Ot Equator GUDID
Generic name
Dental implant suprastructure, permanent, preformed
Device name
330SBEY
Model / Ref / Catalog
*SMART BOX, 330SBEY, SMART BOX OT EQUATOR
Primary DI / UDI-DI
08059224151526
Basic UDI-DI
B-08059224151526
FDA product code
EGG
EMDN code
Q010299 Prosthetic dentistry devices - other
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.3165
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
*SMART BOX
330SBEY
GUDID
SMART BOX OT EQUATOR
Device classEUDAMED
Class IIa
GUDID
Class I
ImplantableEUDAMED
No
GUDID
Yes

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under DEVICES FOR PROSTHETIC DENTISTRY.

Other devices from Rhein 83 SRL

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Properties

  • Sterilise before use
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)