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FDA 510(k)

EDTA ROOT CANAL CLEANSER

K-Number: K003422 · 2001-01-19

ApplicantSuper Glide, Inc.
Decision Date2001-01-19
Product CodeKJJ
DecisionSubstantially Equivalent

Device Summary

EDTA ROOT CANAL CLEANSER is the device name listed in this FDA 510(k) record. The listed applicant is Super Glide, Inc.. It received FDA 510(k) clearance on 2001-01-19 under 510(k) number K003422. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDTA ROOT CANAL CLEANSER?

EDTA ROOT CANAL CLEANSER is a medical device that received FDA 510(k) clearance on 2001-01-19. The listed applicant is Super Glide, Inc.. The 510(k) number is K003422.

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

EDTA ROOT CANAL CLEANSER received FDA 510(k) clearance on 2001-01-19, under 510(k) number K003422.

Who is the listed applicant for EDTA ROOT CANAL CLEANSER?

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

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

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

Related Clinical Trials

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.

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Other records listing Super Glide, 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.

K992919OXY-GLIDE ROOT CANAL CLEANSER & LUB.

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

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

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