Skip to content

Parkell® D588

by Parkell, Inc.

Ref D588

Parkell® D588 is a device classified as Class I in the EU and Class II in the US made by Parkell, Inc., registered in EUDAMED on 17 Nov 2022 (Basic UDI-DI 081000052ORINGUT) and listed in FDA GUDID since 20 Oct 2023 (UDI-DI 10810000520630), active as of 23 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 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
United StatesGUDID listing GUDID Number10810000520630 UDI-DI Date20 Oct 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number081000052ORINGUT Basic UDI-DI 10810000520630UDI-DIDate17 Nov 2022RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081000052ORINGUT registered 17 Nov 2022 Active
  • FDA GUDID UDI-DI 10810000520630 listed 20 Oct 2023 Listed

Timeline

2 dated events

  1. Registered EUDAMED 081000052ORINGUT
  2. Listed FDA GUDID 10810000520630

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  • Withdrawn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
Parkell®
Generic name
Ultrasonic dental scaling/debridement system handpiece
Device name
O-Ring
Model / Ref / Catalog
D588
Primary DI / UDI-DI
10810000520630
Basic UDI-DI
081000052ORINGUT
Unit of use DI
00810000520633
FDA product code
ELC
EMDN code
Z12119001 Tartar ablators
GMDN term
Ultrasonic dental scaling/debridement system handpiece
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.4850
EU registration type
Standard device
EU market of registration
Germany
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.

Related devices

Category: Ultrasonic dental scaling/debridement system handpiece

Similar devices in this category

Other devices filed under TARTAR ABLATORS.

Other devices from Parkell, Inc.

See all devices from Parkell, Inc. →

Properties

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