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X-Smart Pro 6779008

by SIRONA Dental Systems GmbH

Ref 6779008

X-Smart Pro 6779008 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 10 Aug 2026 (Basic UDI-DI ++E276EndoTTV01SV) and listed in FDA GUDID since 29 Jul 2024 (UDI-DI +E27667790080), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E276EndoTTV01SV Basic UDI-DI +E27667790080UDI-DIDate10 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+E27667790080 UDI-DI Date29 Jul 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++E276EndoTTV01SV registered 10 Aug 2026 Active
  • FDA GUDID UDI-DI +E27667790080 listed 29 Jul 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID +E27667790080
  2. Registered EUDAMED ++E276EndoTTV01SV

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
X-Smart Pro
Generic name
Dental surgical power tool motorized handpiece/set, electric
Device name
Endo Tabletop
Model / Ref / Catalog
6779008
Primary DI / UDI-DI
+E27667790080 EUDAMED
E27667790080 GUDID
Basic UDI-DI
++E276EndoTTV01SV
FDA product code
EKX, LQY
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
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+E27667790080
GUDID
E27667790080
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
Yes
GUDID
No

The registries describe this device under different primary UDI-DIs (EUDAMED lists +E27667790080; FDA GUDID lists E27667790080), 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, electric

Similar devices in this category

Other devices filed under DENTAL TREATMENT UNITS.

Other devices from SIRONA Dental Systems GmbH

See all devices from SIRONA Dental Systems GmbH →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Measuring function
  • Prescription use
  • Serial number
Other properties (21, all answered No)