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FDA 510(k)

DENTSPLY G-106 CAVITRON ULTRASONIC

K-Number: K834283 · 1984-03-16

ApplicantCoopercare, Inc.
Decision Date1984-03-16
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTSPLY G-106 CAVITRON ULTRASONIC is the device name listed in this FDA 510(k) record. The listed applicant is Coopercare, Inc.. It received FDA 510(k) clearance on 1984-03-16 under 510(k) number K834283. 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 DENTSPLY G-106 CAVITRON ULTRASONIC?

DENTSPLY G-106 CAVITRON ULTRASONIC is a medical device that received FDA 510(k) clearance on 1984-03-16. The listed applicant is Coopercare, Inc.. The 510(k) number is K834283.

When did DENTSPLY G-106 CAVITRON ULTRASONIC receive FDA 510(k) clearance?

DENTSPLY G-106 CAVITRON ULTRASONIC received FDA 510(k) clearance on 1984-03-16, under 510(k) number K834283.

Who is the listed applicant for DENTSPLY G-106 CAVITRON ULTRASONIC?

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

What is the FDA product code for DENTSPLY G-106 CAVITRON ULTRASONIC?

The FDA product code for DENTSPLY G-106 CAVITRON ULTRASONIC is ELC.

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 Coopercare, 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.

K832949SANODENT DOUBLE-ENDED INTERDENTAL CLEAN

Related Devices (Code: ELC)

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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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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