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Z217399

by Nakanishi Inc.

Ref Z217399Model MDA0000030

Z217399 is an ultrasonic dental scaling/debridement system (EU MDR Class I; FDA Class II; FDA product code ELC, Scaler, ultrasonic) made by Nakanishi Inc., registered in EUDAMED on 31 Jul 2026 (Basic UDI-DI 45602249800002177C), cleared under FDA 510(k) K113530 on 31 Jan 2013 and listed in FDA GUDID since 21 Jan 2026 (UDI-DI 04589551386710), 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 linked in EUDAMED

A group certificate may exist

510(k) K113530

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 Number45602249800002177C Basic UDI-DI 04589551386710UDI-DIDate31 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04589551386710 UDI-DI Date21 Jan 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK113530 Date31 Jan 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 45602249800002177C registered 31 Jul 2026 Active
  • FDA 510(k) K113530 decided 31 Jan 2013 Active
  • FDA GUDID UDI-DI 04589551386710 listed 21 Jan 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K113530
  2. Listed FDA GUDID 04589551386710
  3. Registered EUDAMED 45602249800002177C

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  • Withdrawn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
E Tip Wrench
Generic name
Ultrasonic dental scaling/debridement system
Model / reference
MDA0000030 EUDAMED
Z217399 EUDAMED
E TIP WRENCH GUDID
Primary DI / UDI-DI
04589551386710
Basic UDI-DI
45602249800002177C
Direct marketing DI
04589551382828
510(k) Number
FDA product code
ELC
EMDN code
Z12119080 Various dental stomatology instruments - hardware accessories
GMDN term
Ultrasonic dental scaling/debridement system
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
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
MDA0000030
Z217399
GUDID
E TIP WRENCH
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
JP-MF-000011271
Authorised representative
NSK Europe GmbH DE-AR-000007040

Similar devices in this category

Other devices filed under VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Nakanishi Inc.

See all devices from Nakanishi Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)