Skip to content

Ceramic Bracket

by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda 288 variants

Ref 21.02.2003, 10.93.3006, 30.10.3005, 21.02.2005, 30.10.3001, 30.10.3006, 21.02.2001, 30.10.3007, 21.02.2007, 21.02.2006, 21.02.2004, 30.10.3004, 10.93.3233, 30.10.3002

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number79084707CERAMICW5 Basic UDI-DI Date21 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07908611204097 UDI-DI Date24 May 2023ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
Ceramic Bracket Iceram-P
Iceram Ceramic Button for Bonding - 10 Un
Iceram Ceramic Button for Bonding - 2UN
Ceramic Mini Tube -10UN
Generic Name
Orthodontic bracket, ceramic
Orthodontic bracket, metal
Orthodontic tube
Device Name
Ceramic Bracket
Model / Ref / Catalog
21.02.2003, 10.93.3006, 30.10.3005, 21.02.2005, 30.10.3001, 30.10.3006, 21.02.2001, 30.10.3007, 21.02.2007, 21.02.2006, 21.02.2004, 30.10.3004, 10.93.3233, 30.10.3002
Primary DI / UDI-DI
07908611204097, 07908611203489, 07908611204189, 07908611204110, 07908611204141, 07908611204196, 07908611204073, 07908611204202, 07908611204134, 07908611204127, 07908611204103, 07908611204172, 07908611203991, 07908611204158
Basic UDI-DI
79084707CERAMICW5
510(k) Number
FDA Product Code
NJM, DZD
EMDN Code
Q010403 Orthodontic brackets and buttons
GMDN Term
Orthodontic bracket, ceramic
Orthodontic bracket, metal
Orthodontic tube
Device Class
Class IIa EUDAMED
Class II GUDID
Class I GUDID
Regulation Number
872.5470, 872.5410
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II
Class I

Manufacturer details

EUDAMED SRN
BR-MF-000026426
Authorised representative
Cinterqual-Soluções de Comércio Internacional,Lda. PT-AR-000002813

Other devices from Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda

See all devices from Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda →

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit NoGUDIDYesGUDID
  • Premarket Exempt NoGUDIDYesGUDID
  • Lot / Batch Number
  • Expiration Date YesGUDIDNoGUDID
  • Manufacturing Date NoGUDIDYesGUDID

Other properties (17)

  • Sterile: 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
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No