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GentleCLEAN™

by Parkell Inc. 3 variants

Ref DSG30GCT

GentleCLEAN (DSG30GCT) is a medical device (EU MDD Class IIa; FDA Class II; FDA product code ELC, Scaler, Ultrasonic; EMDN category tartar ablators) made by Parkell, Inc., registered in EUDAMED on 23 Nov 2022 (Basic UDI-DI B-10810000522733) and listed in FDA GUDID since 2 Nov 2018 (UDI-DI 10810000522733), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10810000522733 Basic UDI-DI 10810000522733UDI-DIDate23 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number10810000522733 UDI-DI Date2 Nov 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10810000522733 registered 23 Nov 2022 Active
  • FDA GUDID UDI-DI 10810000522733 listed 2 Nov 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10810000522733
  2. Registered EUDAMED B-10810000522733

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  • Withdrawn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
Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Model / Ref / Catalog
DSG30GCT
Primary DI / UDI-DI
10810000522733
Basic UDI-DI
B-10810000522733
FDA product code
ELC
EMDN code
Z12119001 Tartar ablators
GMDN term
Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.4850
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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-000003761
Authorised representative
Directa AB SE-AR-000002492

Similar devices in this category

Other devices filed under TARTAR ABLATORS.

Other devices from Parkell, Inc.

See all devices from Parkell, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)