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Traxodent Value Pack

by Premier Dental Products Company

Ref 9007091

Traxodent Value Pack (9007091) is a gingival retraction solution (EU MDR Class IIa; FDA unclassified; FDA product code MVL, Cord, Retraction) made by Premier Dental Products Company, registered in EUDAMED on 13 Mar 2024 (Basic UDI-DI 0348783traxodentLE), cleared under FDA 510(k) K083695 on 28 Apr 2009 and listed in FDA GUDID since 14 Dec 2022 (UDI-DI 00348783000269), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 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) K083695

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0348783traxodentLE Basic UDI-DI 00348783000269UDI-DIDate13 Mar 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00348783000269 UDI-DI Date14 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK083695 Date28 Apr 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0348783traxodentLE registered 13 Mar 2024 Active
  • FDA 510(k) K083695 decided 28 Apr 2009 Active
  • FDA GUDID UDI-DI 00348783000269 listed 14 Dec 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K083695
  2. Listed FDA GUDID 00348783000269
  3. Registered EUDAMED 0348783traxodentLE

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Traxodent Value Pack EUDAMED
Traxodent GUDID
Generic name
Gingival retraction solution
Device name
Traxodent Hemostatic Retraction Paste
Model / reference
9007091
Primary DI / UDI-DI
00348783000269
Basic UDI-DI
0348783traxodentLE
Direct marketing DI
00348783000269
510(k) Number
FDA product code
MVL
EMDN code
Q010204 Retraction wires and gingival retractors
GMDN term
Gingival retraction solution
Device class
Class IIa EUDAMED
U GUDID
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
U

Device class is stated on each registry's own scale: Class IIa 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-000015778
Authorised representative
MDSS GmbH DE-AR-000005430

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 Premier Dental Products Company

See all devices from Premier Dental Products Company →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (21, all answered No)