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FDA 510(k)

CLEANSER, ROOT CANAL

K-Number: K802853 · 1980-12-18

ApplicantDentsply Intl.
Decision Date1980-12-18
Product CodeKJJ
DecisionSubstantially Equivalent

Device Summary

CLEANSER, ROOT CANAL is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1980-12-18 under 510(k) number K802853. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEANSER, ROOT CANAL?

CLEANSER, ROOT CANAL is a medical device that received FDA 510(k) clearance on 1980-12-18. The listed applicant is Dentsply Intl.. The 510(k) number is K802853.

When did CLEANSER, ROOT CANAL receive FDA 510(k) clearance?

CLEANSER, ROOT CANAL received FDA 510(k) clearance on 1980-12-18, under 510(k) number K802853.

Who is the listed applicant for CLEANSER, ROOT CANAL?

The FDA 510(k) record lists Dentsply Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEANSER, ROOT CANAL?

The FDA product code for CLEANSER, ROOT CANAL is KJJ.

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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.

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