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Etchmaster EMTRS50

by Reliance Orthodontic Products, Inc.

Ref EMTRS50Model Orthodontic Accessories

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, self-declared

Class I: no certifier involved

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 Number840479ORTHOACCESSORIESBR Basic UDI-DI 00840479201313UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840479201313 UDI-DI Date4 Mar 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
Etchmaster Tips EUDAMED
Etchmaster GUDID
Generic Name
Dental material injection cannula, single-use
Model / Reference
EMTRS50, Orthodontic Accessories
Primary DI / UDI-DI
00840479201313
Basic UDI-DI
840479ORTHOACCESSORIESBR
510(k) Number
FDA Product Code
KOJ
EMDN Code
Q010599 Dental instruments, single-use - other
GMDN Term
Dental material injection cannula, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.6080
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K030292)

Show all (12)

Other devices from Reliance Orthodontic Products, Inc.

See all devices from Reliance Orthodontic Products, Inc. →

Properties

  • Single Use
  • Lot / Batch Number

Other properties (22)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No