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FDA 510(k)

CAVITRON JET WITH SPS SYSTEM

K-Number: K970342 · 1997-04-04

ApplicantDentsply Intl.
Decision Date1997-04-04
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CAVITRON JET WITH SPS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1997-04-04 under 510(k) number K970342. 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 JET WITH SPS SYSTEM?

CAVITRON JET WITH SPS SYSTEM is a medical device that received FDA 510(k) clearance on 1997-04-04. The listed applicant is Dentsply Intl.. The 510(k) number is K970342.

When did CAVITRON JET WITH SPS SYSTEM receive FDA 510(k) clearance?

CAVITRON JET WITH SPS SYSTEM received FDA 510(k) clearance on 1997-04-04, under 510(k) number K970342.

Who is the listed applicant for CAVITRON JET WITH SPS SYSTEM?

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 CAVITRON JET WITH SPS SYSTEM?

The FDA product code for CAVITRON JET WITH SPS 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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