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FDA 510(k)

MICROJET CAVITY PREPARATION SYSTEM

K-Number: K964755 · 1997-09-11

ApplicantMidwest Dental Products Corp.
Decision Date1997-09-11
Product CodeKOJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MICROJET CAVITY PREPARATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Midwest Dental Products Corp.. It received FDA 510(k) clearance on 1997-09-11 under 510(k) number K964755. 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 MICROJET CAVITY PREPARATION SYSTEM?

MICROJET CAVITY PREPARATION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-09-11. The listed applicant is Midwest Dental Products Corp.. The 510(k) number is K964755.

When did MICROJET CAVITY PREPARATION SYSTEM receive FDA 510(k) clearance?

MICROJET CAVITY PREPARATION SYSTEM received FDA 510(k) clearance on 1997-09-11, under 510(k) number K964755.

Who is the listed applicant for MICROJET CAVITY PREPARATION SYSTEM?

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

What is the FDA product code for MICROJET CAVITY PREPARATION SYSTEM?

The FDA product code for MICROJET CAVITY PREPARATION SYSTEM is KOJ.

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 Midwest Dental Products Corp. 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.

K97380023:1 REDUCTION ANGLEK962877MIDWEST 300 SEK963050TRADITION P, PUSH BUTTON HANDPIECEK955655MIDWEST ONE

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.

K251425turbodent touchMectron S.P.A.K063236BETA-POWDERBrainbase CorporationK042872RONDOFLEX PLUS 360Kavo America CorporationK033675PROSMILE AIR POLISHER AND PROPHYLAXIS POWDERSirona Dental Systems GmbHK033215PREPAIRDanville Materials, Inc.K024105VELOPEX AQUACUT FLUID ABRASION UNITVelopex International, Inc.

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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