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)

BEAUTIFIL Flow Plus X

K-Number: K172530 · 2017-12-06

Decision Date2017-12-06
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BEAUTIFIL Flow Plus X is a medical device manufactured by Shofu Dental Corporation. It received FDA 510(k) clearance on 2017-12-06 under approval number K172530. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEAUTIFIL Flow Plus X?

BEAUTIFIL Flow Plus X is a medical device that received FDA 510(k) clearance on 2017-12-06. It is manufactured by Shofu Dental Corporation. The 510(k) number is K172530.

When was BEAUTIFIL Flow Plus X approved by the FDA?

BEAUTIFIL Flow Plus X received FDA 510(k) clearance on 2017-12-06, under approval number K172530.

What company makes BEAUTIFIL Flow Plus X?

BEAUTIFIL Flow Plus X is manufactured by Shofu Dental Corporation.

What is the FDA product code for BEAUTIFIL Flow Plus X?

The FDA product code for BEAUTIFIL Flow Plus X is EBF.

Other Devices by Shofu Dental Corporation

View all 23 devices →

Related Devices (Code: EBF)

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.