Basis Hi 1kg, Lf Pink

by Yamahachi Dental Mfg., Co.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 GUDID	NumberD080XXBHIX1KGXXLFP0 UDI-DI	Date2 Oct 2023Listed	StatusListed GUDID: in commercial distribution
European Union	CE/MDD EUDAMED	Number—	Date—	StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name: Basis Hi
Generic Name: Dental appliance fabrication material, resin
Model / Reference: 1KG, LF PINK

Primary DI / UDI-DI: D080XXBHIX1KGXXLFP0
510(k) Number: K131036
FDA Product Code: EBI
GMDN Term: Dental appliance fabrication material, resin

Device Class: Class II
Regulation Number: 872.3760
GUDID distribution status: In Commercial Distribution

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See all devices from Yamahachi Dental Mfg., Co. →

Properties

Single Use
Prescription Use
Lot / Batch Number
Expiration Date

Other properties (10)

Sterile: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Manufacturing Date: No