Azure 59.089/3

by Terrats Medical SL

Azure 59.089/3 (ARBHI-TBCH573) is a Class II device made by Terrats Medical SL, cleared under FDA 510(k) K222288 on 27 Oct 2022 and listed in FDA GUDID since 19 Apr 2024 (UDI-DI 08435750406420), 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	Number08435750406420 UDI-DI	Date19 Apr 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK222288	Date27 Oct 2022Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08435750406420
FDA 510(k) database 510(k) number K222288

Across registries

2 registries list this device

FDA 510(k) K222288 decided 27 Oct 2022 Active
FDA GUDID UDI-DI 08435750406420 listed 19 Apr 2024 Listed

Timeline

2 dated events

27 Oct 2022 Cleared FDA 510(k) K222288
19 Apr 2024 Listed FDA GUDID 08435750406420

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Azure
Generic name: Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog: 59.089/3, ARBHI-TBCH573

Primary DI / UDI-DI: 08435750406420
510(k) Number: K222288
FDA product code: NHA
GMDN term: Dental implant suprastructure, permanent, preformed

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)