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FDA 510(k)

PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM

K-Number: K974655 · 1998-07-09

ApplicantPrep Technology Corp.
Decision Date1998-07-09
Product CodeKOJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Prep Technology Corp.. It received FDA 510(k) clearance on 1998-07-09 under 510(k) number K974655. 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 PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM?

PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM is a medical device that received FDA 510(k) clearance on 1998-07-09. The listed applicant is Prep Technology Corp.. The 510(k) number is K974655.

When did PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM receive FDA 510(k) clearance?

PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM received FDA 510(k) clearance on 1998-07-09, under 510(k) number K974655.

Who is the listed applicant for PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM?

The FDA 510(k) record lists Prep Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM?

The FDA product code for PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM is KOJ.

Related Clinical Trials

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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.

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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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