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Torqtech St-Dh

by J.morita Mfg.corp.

Ref ST-DHModel TORQTECH

Torqtech St-Dh is a dental surgical power tool motorized handpiece/set (EU MDD Class IIa; FDA Class I; FDA product code EGS, Handpiece, Contra- And Right-Angle Attachment, Dental) made by J.morita Mfg.corp., registered in EUDAMED on 19 Oct 2026 (Basic UDI-DI B-04548213016617), cleared under FDA 510(k) K103697 on 20 Jan 2012 and listed in FDA GUDID since 12 Dec 2022 (UDI-DI 04548213016617), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K103697

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04548213016617 Basic UDI-DI 04548213016617UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04548213016617 UDI-DI Date12 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK103697 Date20 Jan 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04548213016617 registered 19 Oct 2026 Active
  • FDA 510(k) K103697 decided 20 Jan 2012 Active
  • FDA GUDID UDI-DI 04548213016617 listed 12 Dec 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K103697
  2. Listed FDA GUDID 04548213016617
  3. Registered EUDAMED B-04548213016617

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Torqtech
Generic name
Dental surgical power tool motorized handpiece/set, electric
Model / reference
ST-DH, TORQTECH
Primary DI / UDI-DI
04548213016617
Basic UDI-DI
B-04548213016617
510(k) Number
FDA product code
EGS
EMDN code
Z12110101 Dental treatment units
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

Cleared under the same submission (K103697)

and 5 more cleared under K103697

Similar devices in this category

Other devices filed under DENTAL TREATMENT UNITS.

Other devices from J.morita Mfg.corp.

See all devices from J.morita Mfg.corp. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (18, all answered No)