Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Denture Base

K-Number: K243103 · 2024-12-23

ApplicantRiton 3D Technology Co., Ltd.
Decision Date2024-12-23
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Denture Base is a medical device manufactured by Riton 3D Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-12-23 under approval number K243103. 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 Denture Base?

Denture Base is a medical device that received FDA 510(k) clearance on 2024-12-23. It is manufactured by Riton 3D Technology Co., Ltd.. The 510(k) number is K243103.

When was Denture Base approved by the FDA?

Denture Base received FDA 510(k) clearance on 2024-12-23, under approval number K243103.

What company makes Denture Base?

Denture Base is manufactured by Riton 3D Technology Co., Ltd..

What is the FDA product code for Denture Base?

The FDA product code for Denture Base is EBI.

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

View on FDA Database →

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

↑