Skip to content

Optiband Ultra, 5 Syringe Kit, Tooth Color 2-1491

by Ormco Corporation

Ref 740-0291, 112-0421

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00889989075397 Basic UDI-DI Date18 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00889989075397 UDI-DI Date8 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Twnbkt Dmd Med Lat +7TRQ +8ANG 022LT EUDAMED
OptiBand Ultra GUDID
Generic Name
Orthodontic bracket adhesive
Model / Reference
740-0291, 112-0421
Primary DI / UDI-DI
00889989075397, 00889989080186
Basic UDI-DI
B-00889989075397, B-00889989080186
FDA Product Code
DYH
EMDN Code
Q0101010203, Q010402
GMDN Term
Orthodontic bracket adhesive
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3750
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Weight — 9 Gram

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000038085
Authorised representative
KERR ITALIA SRL IT-AR-000007600

Other devices from Ormco Corporation

See all devices from Ormco Corporation →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No