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Etchmaster Tips

by Reliance Orthodontic Products, Inc.

Part of a family of 69 devices: see the family page

Ref EMTLS50Model Orthodontic Accessories

Etchmaster Tips (EMTLS50) is a dental material injection cannula (EU MDR Class I; FDA Class II; FDA product code KOJ, Airbrush) made by Reliance Orthodontic Products, Inc., registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI 840479ORTHOACCESSORIESBR), cleared under FDA 510(k) K030292 on 15 Apr 2003 and listed in FDA GUDID since 4 Mar 2026 (UDI-DI 00840479201283), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K030292

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number840479ORTHOACCESSORIESBR Basic UDI-DI 00840479201283UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840479201283 UDI-DI Date4 Mar 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK030292 Date15 Apr 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 840479ORTHOACCESSORIESBR registered 16 Oct 2026 Active
  • FDA 510(k) K030292 decided 15 Apr 2003 Active
  • FDA GUDID UDI-DI 00840479201283 listed 4 Mar 2026 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K030292
  2. Listed FDA GUDID 00840479201283
  3. Registered EUDAMED 840479ORTHOACCESSORIESBR

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Etchmaster Tips EUDAMED
Etchmaster GUDID
Generic name
Dental material injection cannula, single-use
Model / reference
Orthodontic Accessories, EMTLS50
Primary DI / UDI-DI
00840479201283
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 registration type
Standard device
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

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000013812
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under DENTAL INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Reliance Orthodontic Products, Inc.

See all devices from Reliance Orthodontic Products, Inc. →

Properties

  • Single use
  • Lot / batch number
Other properties (23, all answered No)