Basis HI 40g*25ml, LF α

by Yamahachi Dental Mfg., Co.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

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	Number04582594041387 UDI-DI	Date20 Nov 2021Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Basis HI
Generic Name: Dental appliance fabrication material, resin
Model / Reference: 40g*25ml, LF α

Primary DI / UDI-DI: 04582594041387
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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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