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Racegel

by Septodont

510(k) K093711Ref 287/3

Racegel is a medical device (EU MDD Class I; FDA unclassified; FDA product code MVL, Cord, Retraction; EMDN category retraction wires and gingival retractors) made by Septodont, registered in EUDAMED on 15 Apr 2026 (Basic UDI-DI B-FR-MF-00001699200038PU) and cleared under FDA 510(k) K093711 on 17 Feb 2010, active as of 22 Oct 2026.

Active European Union and United States

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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K093711↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-FR-MF-00001699200038PU Basic UDI-DI D-FR-MF-00001699200038PUUDI-DIDate15 Apr 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK093711 Date17 Feb 2010ClearedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-FR-MF-00001699200038PU registered 15 Apr 2026 Active
  • FDA 510(k) K093711 decided 17 Feb 2010 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K093711
  2. Registered EUDAMED B-FR-MF-00001699200038PU

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  • Withdrawn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 · 510(k)

Model / reference
287/3
Primary DI / UDI-DI
D-FR-MF-00001699200038PU
Basic UDI-DI
B-FR-MF-00001699200038PU
510(k) Number
FDA product code
MVL
EMDN code
Q010204 Retraction wires and gingival retractors
Device class
Class I EUDAMED
U 510(k)
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
Advisory committee
Unknown
FDA decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device classEUDAMED
Class I
510(k)
U

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), U in the US (FDA 510(k)). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices in this category

Other devices filed under RETRACTION WIRES AND GINGIVAL RETRACTORS.

Other devices from Septodont

See all devices from Septodont →

Properties

Other properties (12, all answered No)