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FDA 510(k)

CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM

K-Number: K130862 · 2013-07-23

ApplicantDentsply Intl., Inc.
Decision Date2013-07-23
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl., Inc.. It received FDA 510(k) clearance on 2013-07-23 under 510(k) number K130862. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM?

CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM is a medical device that received FDA 510(k) clearance on 2013-07-23. The listed applicant is Dentsply Intl., Inc.. The 510(k) number is K130862.

When did CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM receive FDA 510(k) clearance?

CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM received FDA 510(k) clearance on 2013-07-23, under 510(k) number K130862.

Who is the listed applicant for CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM?

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

What is the FDA product code for CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM?

The FDA product code for CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM is ELC.

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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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