Na Hk-Y-0.4

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

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number06935835600009 UDI-DI	Date9 Oct 2023Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name: Dental appliance fabrication material, thermoplastic
Model / Reference: HK-Y-0.4

Primary DI / UDI-DI: 06935835600009
510(k) Number: K230237
FDA Product Code: MQC, KMY
GMDN Term: Dental appliance fabrication material, thermoplastic

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

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Properties

Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (11)

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
Premarket Exempt: No
Serial Number: No