Skip to content

Water Filter Set (2m)

by Nakanishi Inc. EUDAMEDGUDID

Active European Union

Ref U387040Model MDA0000127

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04560264501980 UDI-DIDate1 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number45602249800001277A Basic UDI-DIDate31 Jul 2026RegisteredStatusActive

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · FDA

    • Terminated Z-2672-2016 FDA Class II initiated 8 Jul 2016

    Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are multiple use and are not limited to single use only. The tips are stainless steel with a coating of fine diamond powder. The tips are sold non-sterile and are to be sterilized prior to first use. The tips were cleared as single use only. This problem was discovered during an ongoing, proactive, quality system improvement plan that was initiated by Nakanishi in October 2014. Because the correct instructions for sterilization are not available, it is possible that the devices might not be sterile prior to use. The absence of the single use statement introduces a risk of cross-contamination if the tips are reprocessed and reused.

Specification

EUDAMED · GUDID

Generic Name
Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Model / Reference
MDA0000127 EUDAMED
U387040 EUDAMED
Water Filter Set (2m) GUDID
Primary DI / UDI-DI
04560264501980
Basic UDI-DI
45602249800001277A
510(k) Number
FDA Product Code
ELC
EMDN Code
Z12119080 Various dental stomatology instruments - hardware accessories
GMDN Term
Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.4850
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MDA0000127
U387040
GUDID
Water Filter Set (2m)
Device ClassEUDAMED
Class I
GUDID
Class II

Other devices from Nakanishi Inc.

See all devices from Nakanishi Inc. →

Properties

  • Prescription Use
  • Manufacturing Date

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No