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Eclipse Passive 463-901

by Ortho Arch Company

Ref 463-901Model 018 ECLIPSE PASSIVE SLB ROTH 5x5 U&L

Eclipse Passive 463-901 is a self-ligating orthodontic bracket (EU MDD Class IIa; FDA Class I; FDA product code EJF, Bracket, Metal, Orthodontic) made by Ortho Arch Company, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-+D9094639011A) and listed in FDA GUDID since 21 Jun 2023 (UDI-DI +D9094639011A), active as of 8 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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+D9094639011A Basic UDI-DI +D9094639011AUDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+D9094639011A UDI-DI Date21 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-+D9094639011A registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI +D9094639011A listed 21 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID +D9094639011A
  2. Registered EUDAMED B-+D9094639011A

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  • Withdrawn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
Eclipse Passive
Generic name
Self-ligating orthodontic bracket
Model / Ref / Catalog
463-901, 018 ECLIPSE PASSIVE SLB ROTH 5x5 U&L
Primary DI / UDI-DI
+D9094639011A EUDAMED
D9094639011 GUDID
Basic UDI-DI
B-+D9094639011A
FDA product code
EJF
EMDN code
Q010403 Orthodontic brackets and buttons
GMDN term
Self-ligating orthodontic bracket
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.5410
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
Primary DI / UDI-DIEUDAMED
+D9094639011A
GUDID
D9094639011
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists +D9094639011A; FDA GUDID lists D9094639011), so their flags are not compared. 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.

Related devices

Category: Self-ligating orthodontic bracket

Similar devices in this category

Other devices filed under ORTHODONTIC BRACKETS AND BUTTONS.

Other devices from Ortho Arch Company

See all devices from Ortho Arch Company →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)