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FDA 510(k)

NEW PROPHY POWDER

K-Number: K014188 · 2002-03-15

Decision Date2002-03-15
Product CodeKOJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NEW PROPHY POWDER is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2002-03-15 under 510(k) number K014188. The device is classified under product code KOJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEW PROPHY POWDER?

NEW PROPHY POWDER is a medical device that received FDA 510(k) clearance on 2002-03-15. The listed applicant is Dentsply Intl.. The 510(k) number is K014188.

When did NEW PROPHY POWDER receive FDA 510(k) clearance?

NEW PROPHY POWDER received FDA 510(k) clearance on 2002-03-15, under 510(k) number K014188.

Who is the listed applicant for NEW PROPHY POWDER?

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 NEW PROPHY POWDER?

The FDA product code for NEW PROPHY POWDER is KOJ.

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.

View all 279 devices →

Related Devices (Code: KOJ)

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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