FDA 510(k)

BASIS FLOW II

K-Number: K233859 · 2024-03-05

Decision Date2024-03-05

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

BASIS FLOW II is a medical device manufactured by YAMAHACHI DENTAL MFG., Co.. It received FDA 510(k) clearance on 2024-03-05 under approval number K233859. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BASIS FLOW II?

BASIS FLOW II is a medical device that received FDA 510(k) clearance on 2024-03-05. It is manufactured by YAMAHACHI DENTAL MFG., Co.. The 510(k) number is K233859.

When was BASIS FLOW II approved by the FDA?

BASIS FLOW II received FDA 510(k) clearance on 2024-03-05, under approval number K233859.

What company makes BASIS FLOW II?

BASIS FLOW II is manufactured by YAMAHACHI DENTAL MFG., Co..

What is the FDA product code for BASIS FLOW II?

The FDA product code for BASIS FLOW II is EBI.

Other Devices by YAMAHACHI DENTAL MFG., Co.

K172683Yamahachi Pink CAD/CAM Disk K254091GLOSSY COAT (15ML)

Related Devices (Code: EBI)

K161330Pour AcrylicDentsply Sirona K153546PINK CAD/CAM discPolident D.O.O., Dental Products Industry K152981JET SET 4 DENTURE REPAIR RESINLang Dental Manufacturing Company, Inc. K160498Dentivera Milling DiscDental Solutions, LLC K153590AvaDent Denture Base MaterialGlobal Dental Science K152051ClearMetMycone Dental Supply Co., T/A Keystone Industries

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.