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FDA 510(k)

ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30

K-Number: K864996 · 1987-02-19

Decision Date1987-02-19
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30 is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1987-02-19 under 510(k) number K864996. 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 ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30?

ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30 is a medical device that received FDA 510(k) clearance on 1987-02-19. The listed applicant is Dentsply Intl.. The 510(k) number is K864996.

When did ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30 receive FDA 510(k) clearance?

ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30 received FDA 510(k) clearance on 1987-02-19, under 510(k) number K864996.

Who is the listed applicant for ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30?

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 ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30?

The FDA product code for ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30 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.

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: 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.

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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