Na Hk-T-0.9

by Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number06975656780153 UDI-DI	Date31 Jan 2023Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: Orthodontic progressive aligner
Model / Reference: HK-T-0.9

Primary DI / UDI-DI: 06975656780153
FDA Product Code: DYT
GMDN Term: Orthodontic progressive aligner

Device Class: Class I
Regulation Number: 872.5525
GUDID distribution status: In Commercial Distribution

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Properties

Premarket Exempt

Other properties (13)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Lot / Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No