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Premier Scalers

by Premier Dental Products Company 7 variants

Ref 1004686

Premier Scalers (1004686) is a Class I device made by Premier Dental Products Company, registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI B-00348783007374) and listed in FDA GUDID since 6 May 2026 (UDI-DI 00348783007374), active as of 23 Oct 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00348783007374 Basic UDI-DI 00348783007374UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00348783007374 UDI-DI Date6 May 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00348783007374 registered 5 Oct 2026 Active
  • FDA GUDID UDI-DI 00348783007374 listed 6 May 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00348783007374
  2. Registered EUDAMED B-00348783007374

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Manual dental scaler, reusable
Model / reference
1004686
Primary DI / UDI-DI
00348783007374
Basic UDI-DI
B-00348783007374
FDA product code
EMN
EMDN code
L159009 Odontostomatology scalers, reusable
GMDN term
Manual dental scaler, reusable
Device class
Class I
Regulation number
872.4565
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
US-MF-000015778
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under ODONTOSTOMATOLOGY SCALERS, REUSABLE.

Other devices from Premier Dental Products Company

See all devices from Premier Dental Products Company →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (17, all answered No)