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)

CharmFlex

K-Number: K152766 · 2016-03-08

ApplicantDentkist, Inc.
Decision Date2016-03-08
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CharmFlex is a medical device manufactured by Dentkist, Inc.. It received FDA 510(k) clearance on 2016-03-08 under approval number K152766. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CharmFlex?

CharmFlex is a medical device that received FDA 510(k) clearance on 2016-03-08. It is manufactured by Dentkist, Inc.. The 510(k) number is K152766.

When was CharmFlex approved by the FDA?

CharmFlex received FDA 510(k) clearance on 2016-03-08, under approval number K152766.

What company makes CharmFlex?

CharmFlex is manufactured by Dentkist, Inc..

What is the FDA product code for CharmFlex?

The FDA product code for CharmFlex is ELW.

Other Devices by Dentkist, Inc.

K193496CharmFil

Related Devices (Code: ELW)

K152615Vonflex SVericom Co., Ltd. K161774i-SilSpident Co., Ltd. K160097Image Fast Set, Image Regular SetSybron Dental Specialties K160441Identic and KromaFaze Alginate Dental Impression MaterialsKerr Corporation K152826NoCordCentrix, Inc. K152861Aquasil Ultra + Smart Wetting Impression MaterialDentply International, Inc.

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.

↑