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

FDA 510(k)

ENDO-CHX

K-Number: K070401 · 2007-07-11

ApplicantEssential Dental Systems, Inc.
Decision Date2007-07-11
Product CodeKJJ
DecisionSubstantially Equivalent

Device Summary

ENDO-CHX is the device name listed in this FDA 510(k) record. The listed applicant is Essential Dental Systems, Inc.. It received FDA 510(k) clearance on 2007-07-11 under 510(k) number K070401. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO-CHX?

ENDO-CHX is a medical device that received FDA 510(k) clearance on 2007-07-11. The listed applicant is Essential Dental Systems, Inc.. The 510(k) number is K070401.

When did ENDO-CHX receive FDA 510(k) clearance?

ENDO-CHX received FDA 510(k) clearance on 2007-07-11, under 510(k) number K070401.

Who is the listed applicant for ENDO-CHX?

The FDA 510(k) record lists Essential Dental Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDO-CHX?

The FDA product code for ENDO-CHX is KJJ.

Other records listing Essential Dental Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223340EDS Calculus Softener TURBO CRK152691EDS Universal CementK111541ENDO-EXPRESS (R) HANDPIECEK101504TI-CORE FLOWK072555EDTA PLUSK063856EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM

View all 15 devices →

Related Devices (Code: KJJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250279RC-SwiftPrepBelport Company, Inc., Gingi-PakK241354Sealer SolventInter-Med, Inc.K201785EPIEN Dental CleanserEpien Medical, Inc.K211813TritonInter-Med / Vista DentalK193357V-MixInter-Med/Vista Dental ProductsK193409Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products

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.

↑