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T1 Line 4177015

by SIRONA Dental Systems GmbH

Ref 4177015

T1 Line 4177015 is a device classified as Class IIa in the EU and Class I in the US made by SIRONA Dental Systems GmbH, registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI B-+E27641770150) and listed in FDA GUDID since 28 Mar 2024 (UDI-DI +E27641770150), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+E27641770150 Basic UDI-DI +E27641770150UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+E27641770150 UDI-DI Date28 Mar 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-+E27641770150 registered 21 Oct 2026 Active
  • FDA GUDID UDI-DI +E27641770150 listed 28 Mar 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID +E27641770150
  2. Registered EUDAMED B-+E27641770150

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  • Withdrawn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

Trade name
T1 Line EVA 11 L EUDAMED
T1 Line GUDID
Generic name
Dental surgical power tool motorized handpiece/set, pneumatic
Model / reference
4177015
Primary DI / UDI-DI
+E27641770150 EUDAMED
E27641770150 GUDID
Basic UDI-DI
B-+E27641770150
FDA product code
EFB
EMDN code
Z12110180 Instruments for dental treatment units - hardware accessories
GMDN term
Dental surgical power tool motorized handpiece/set, pneumatic
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 · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+E27641770150
GUDID
E27641770150
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
No
GUDID
Yes

The registries describe this device under different primary UDI-DIs (EUDAMED lists +E27641770150; FDA GUDID lists E27641770150), so their flags are not compared. 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, pneumatic

Similar devices in this category

Other devices filed under INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES.

Other devices from SIRONA Dental Systems GmbH

See all devices from SIRONA Dental Systems GmbH →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)