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Traxodent Value Pack

by Premier Dental Products Company

Ref 9007091

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

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 Number0348783traxodentLE Basic UDI-DI 00348783000269UDI-DIDate13 Mar 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00348783000269 UDI-DI Date14 Dec 2022ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
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 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

Manufacturer details

EUDAMED SRN
US-MF-000015778
Authorised representative
MDSS GmbH DE-AR-000005430

Related devices

Category: Gingival retraction cord, non-medicated

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 (20)

  • Sterile: No
  • Single Use: No
  • 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
  • Premarket Exempt: No
  • Serial Number: No