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Edge X7 Utopia

by FKG Dentaire Sàrl 46 variants

Ref S1.UB1.00.0AO.EEModel S1.7B0.00.0FI.FK

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7640142410401019R Basic UDI-DIDate15 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640142444992 UDI-DIDate19 Apr 2023ListedStatusListed GUDID: in commercial distribution

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.

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  • Withdrawn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

Generic Name
Rotary/reciprocating endodontic file/rasp, single-use
Device Name
R-Motion
Model / Ref / Catalog
S1.7B0.00.0FI.FK EUDAMED
S1.UB1.00.0AO.EE EUDAMED
X7U400425SE GUDID
Primary DI / UDI-DI
07640142444992
Basic UDI-DI
7640142410401019R
FDA Product Code
EKS
EMDN Code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
GMDN Term
Rotary/reciprocating endodontic file/rasp, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.4565
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
S1.7B0.00.0FI.FK
S1.UB1.00.0AO.EE
GUDID
X7U400425SE
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
CH-MF-000017925
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from FKG Dentaire Sàrl

See all devices from FKG Dentaire Sàrl →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • 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
  • Serial Number: No
  • Manufacturing Date: No