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FDA 510(k)

ENDOPURE ROOT CANAL CLEANSER

K-Number: K032361 · 2004-01-12

Decision Date2004-01-12
Product CodeKJJ
DecisionSubstantially Equivalent

Device Summary

ENDOPURE ROOT CANAL CLEANSER is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2004-01-12 under 510(k) number K032361. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOPURE ROOT CANAL CLEANSER?

ENDOPURE ROOT CANAL CLEANSER is a medical device that received FDA 510(k) clearance on 2004-01-12. The listed applicant is Dentsply Intl.. The 510(k) number is K032361.

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

ENDOPURE ROOT CANAL CLEANSER received FDA 510(k) clearance on 2004-01-12, under 510(k) number K032361.

Who is the listed applicant for ENDOPURE ROOT CANAL CLEANSER?

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 ENDOPURE ROOT CANAL CLEANSER?

The FDA product code for ENDOPURE 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.

Other records listing Dentsply Intl. 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.

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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.

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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