Azure 19.425

by Terrats Medical SL

Azure 19.425 (ARDATX-STXTITA45) is a Class II device made by Terrats Medical SL, cleared under FDA 510(k) K173908 on 15 Jun 2018 and listed in FDA GUDID since 5 Sep 2023 (UDI-DI 08435750400572), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08435750400572 UDI-DI	Date5 Sep 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK173908	Date15 Jun 2018Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08435750400572
FDA 510(k) database 510(k) number K173908

Across registries

2 registries list this device

FDA 510(k) K173908 decided 15 Jun 2018 Active
FDA GUDID UDI-DI 08435750400572 listed 5 Sep 2023 Listed

Timeline

2 dated events

15 Jun 2018 Cleared FDA 510(k) K173908
5 Sep 2023 Listed FDA GUDID 08435750400572

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Azure
Generic name: Dental prosthesis/implant abutment screw
Model / Ref / Catalog: 19.425, ARDATX-STXTITA45

Primary DI / UDI-DI: 08435750400572
510(k) Number: K173908
FDA product code: NHA
GMDN term: Dental prosthesis/implant abutment screw

Device class: Class II
Regulation number: 872.3630
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Other devices from Terrats Medical, S.L.

See all devices from Terrats Medical, S.L. →

Properties

Sterilise before use
Single use
Implantable
Prescription use
Lot / batch number

Other properties (10, all answered No)