FDA.reportPublic FDA data

510(k) K233859

Device
BASIS FLOW II
Applicant
YAMAHACHI DENTAL MFG., Co.
510(k) number
K233859
Product code
EBI
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-05
Date received
2023-12-06
Regulation
872.3760
Classification name
Resin, Denture, Relining, Repairing, Rebasing
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Masashi Toyama
Address
54-1 Ochigara, Nishiura-Cho Gamagori JP 443-0105 443-0105

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EBI#

510(k), Device, Applicant table
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K250489FP3DKeystone Industries2025-05-20
K250617Apex FlexSprintray, Inc.2025-04-29
K243356Asiga DentaBASEAsiga Pty, Ltd.2025-04-11
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K243103Denture BaseRiton 3D Technology Co., Ltd.2024-12-23
K243336Lucitone Digital Print Denture™ SystemDentsply Sirona, Inc.2024-12-17