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Traxodent - Itena TRASTRT-2

by Premier Dental Products Company

Traxodent - Itena TRASTRT-2 (7007097) is a gingival retraction solution (FDA unclassified; FDA product code MVL, Cord, Retraction) made by Premier Dental Products Company, cleared under FDA 510(k) K083695 on 28 Apr 2009 and listed in FDA GUDID since 16 Oct 2023 (UDI-DI 00348783001020), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K083695

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00348783001020 UDI-DI Date16 Oct 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK083695 Date28 Apr 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K083695 decided 28 Apr 2009 Active
  • FDA GUDID UDI-DI 00348783001020 listed 16 Oct 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K083695
  2. Listed FDA GUDID 00348783001020

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Traxodent - Itena
Generic name
Gingival retraction solution
Model / Ref / Catalog
TRASTRT-2, 7007097
Primary DI / UDI-DI
00348783001020
510(k) Number
FDA product code
MVL
GMDN term
Gingival retraction solution
Device class
U
GUDID distribution status
In Commercial Distribution

Related devices

Category: Gingival retraction solution

Cleared under the same submission (K083695)

and 6 more cleared under K083695

Similar devices

Other devices filed under FDA product code MVL (Cord, Retraction).

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 (11, all answered No)