Multi M Series HMD3Z25

by DMAX Co., Ltd.

Multi M Series HMD3Z25 is a Class II device made by DMAX Co., Ltd., cleared under FDA 510(k) K250826 on 12 Jun 2025 and listed in FDA GUDID since 4 Aug 2025 (UDI-DI 08800155232477), 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	Number08800155232477 UDI-DI	Date4 Aug 2025Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK250826	Date12 Jun 2025Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08800155232477
FDA 510(k) database 510(k) number K250826

Across registries

2 registries list this device

FDA 510(k) K250826 decided 12 Jun 2025 Active
FDA GUDID UDI-DI 08800155232477 listed 4 Aug 2025 Listed

Timeline

2 dated events

12 Jun 2025 Cleared FDA 510(k) K250826
4 Aug 2025 Listed FDA GUDID 08800155232477

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Multi M Series
Generic name: Dental appliance fabrication material, ceramic
Model / reference: HMD3Z25

Primary DI / UDI-DI: 08800155232477
510(k) Number: K250826
FDA product code: EIH
GMDN term: Dental appliance fabrication material, ceramic

Device class: Class II
Regulation number: 872.6660
GUDID distribution status: In Commercial Distribution

Other devices from DMAX Co., Ltd.

See all devices from DMAX Co., Ltd. →

Properties

Single use
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (10, all answered No)