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Applicators

by Pulpdent Corporation 52 variants

Part of a family of 60 devices: see the family page

Ref PSN-25H

Applicators (PSN-25H) is a Class I device made by Pulpdent Corporation, registered in EUDAMED on 1 Aug 2024 (Basic UDI-DI ++D701APPLAS) and listed in FDA GUDID since 21 Sep 2021 (UDI-DI D701PSN25H2), active as of 22 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++D701APPLAS Basic UDI-DI D701PSN25H2UDI-DIDate1 Aug 2024RegisteredStatusActive
United StatesGUDID listing GUDID NumberD701PSN25H2 UDI-DI Date21 Sep 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++D701APPLAS registered 1 Aug 2024 Active
  • FDA GUDID UDI-DI D701PSN25H2 listed 21 Sep 2021 Listed

Certificates

0 certificates · EUDAMED

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

Timeline

2 dated events

  1. Listed FDA GUDID D701PSN25H2
  2. Registered EUDAMED ++D701APPLAS

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  • Withdrawn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
Pressure Syringe Needles
Generic name
Dental material injection cannula, single-use
Device name
Applicators
Model / reference
PSN-25H
Primary DI / UDI-DI
D701PSN25H2
Basic UDI-DI
++D701APPLAS
Unit of use DI
D701PSN25H1
FDA product code
DZM
EMDN code
Q019006 Dental material application tips and brushes, single-use
GMDN term
Dental material injection cannula, single-use
Device class
Class I
Regulation number
872.4730
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000004897
Authorised representative
Advena Limited MT-AR-000000234

Related devices

Category: Dental material injection cannula, single-use

Similar devices in this category

Other devices filed under DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE.

Other devices from Pulpdent Corporation

See all devices from Pulpdent Corporation →

Properties

  • Single use
  • Premarket exempt
Other properties (23, all answered No)