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Tep-Y

by Nakanishi Inc.

Ref C837Model TEP-Y

Tep-Y is a device classified as Class IIa in the EU and Class I in the US made by Nakanishi Inc., registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI B-04560224971310) and listed in FDA GUDID since 6 Jun 2020 (UDI-DI 04560224971310), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04560224971310 Basic UDI-DI 04560224971310UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04560224971310 UDI-DI Date6 Jun 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04560224971310 registered 14 Oct 2026 Active
  • FDA GUDID UDI-DI 04560224971310 listed 6 Jun 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04560224971310
  2. Registered EUDAMED B-04560224971310

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  • Withdrawn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
Dental surgical power tool motorized handpiece/set, electric
Model / reference
TEP-Y, C837
Primary DI / UDI-DI
04560224971310
Basic UDI-DI
B-04560224971310
FDA product code
EGS
EMDN code
Z12110102 Dental drills
GMDN term
Dental surgical power tool motorized handpiece/set, electric
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4200
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 I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental surgical power tool motorized handpiece/set, electric

Similar devices in this category

Other devices filed under INSTRUMENTS FOR DENTAL TREATMENT UNITS.

Other devices from Nakanishi Inc.

See all devices from Nakanishi Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (22, all answered No)