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Mini Master Series Bracket

by American Orthodontics 1,000+ variants

Ref 390-8337MBUR

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

CE MDR

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

Overview

The Mini Master Series Bracket is a cutting-edge, FDA-approved medical device designed for precise and minimally invasive testing of dental implants. By leveraging advanced instrumentation and sterile technology, this device enables professionals to accurately assess the performance of dental implant systems, facilitating informed treatment decisions.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01907460000137DW Basic UDI-DI 00190746172359UDI-DIDate4 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00190746172359 UDI-DI Date23 Jul 2021ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Mini Master Series Bracket EUDAMED
Mini Master Series GUDID
Generic Name
Orthodontic bracket, metal
Model / Ref / Catalog
390-8337MBUR
Primary DI / UDI-DI
00190746172359
Basic UDI-DI
01907460000137DW
FDA Product Code
EJF
EMDN Code
Q010403 Orthodontic brackets and buttons
GMDN Term
Orthodontic bracket, metal
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.5410
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000007702
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Related devices

Category: Orthodontic tube

Other devices from American Orthodontics

See all devices from American Orthodontics →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No