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Siltrax Plain 00

by Pascal Company Inc.

Ref 07397

Siltrax Plain 00 (07397) is a gingival retraction cord (EU MDR Class I; FDA unclassified; FDA product code MVL, Cord, Retraction) made by Pascal Company, Inc., registered in EUDAMED on 8 Apr 2024 (Basic UDI-DI 03108662001FW) and listed in FDA GUDID since 23 Jan 2019 (UDI-DI 00310866000442), 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 Number03108662001FW Basic UDI-DI 00310866000442UDI-DIDate8 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00310866000442 UDI-DI Date23 Jan 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 03108662001FW registered 8 Apr 2024 Active
  • FDA GUDID UDI-DI 00310866000442 listed 23 Jan 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00310866000442
  2. Registered EUDAMED 03108662001FW

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  • Withdrawn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
Siltrax Plain 00 EUDAMED
SilTrax Plain Retraction Cord 7/00 GUDID
Generic name
Gingival retraction cord, non-medicated
Device name
Siltrax Plain
Model / Ref / Catalog
07397
Primary DI / UDI-DI
00310866000442
Basic UDI-DI
03108662001FW
FDA product code
MVL
EMDN code
Q010204 Retraction wires and gingival retractors
GMDN term
Gingival retraction cord, non-medicated
Device class
Class I EUDAMED
U GUDID
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
U

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

Manufacturer details

EUDAMED SRN
US-MF-000032036
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Gingival retraction cord, non-medicated

Similar devices in this category

Other devices filed under RETRACTION WIRES AND GINGIVAL RETRACTORS.

Other devices from Pascal Company, Inc.

See all devices from Pascal Company, Inc. →

Properties

  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)