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FDA 510(k)

MODEL 2000 DENTAL AIR ABRASIVE SYSTEM

K-Number: K921748 · 1992-11-25

Decision Date1992-11-25
Product CodeKOJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODEL 2000 DENTAL AIR ABRASIVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Texas Airsonics, Inc.. It received FDA 510(k) clearance on 1992-11-25 under 510(k) number K921748. 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 MODEL 2000 DENTAL AIR ABRASIVE SYSTEM?

MODEL 2000 DENTAL AIR ABRASIVE SYSTEM is a medical device that received FDA 510(k) clearance on 1992-11-25. The listed applicant is Texas Airsonics, Inc.. The 510(k) number is K921748.

When did MODEL 2000 DENTAL AIR ABRASIVE SYSTEM receive FDA 510(k) clearance?

MODEL 2000 DENTAL AIR ABRASIVE SYSTEM received FDA 510(k) clearance on 1992-11-25, under 510(k) number K921748.

Who is the listed applicant for MODEL 2000 DENTAL AIR ABRASIVE SYSTEM?

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

What is the FDA product code for MODEL 2000 DENTAL AIR ABRASIVE SYSTEM?

The FDA product code for MODEL 2000 DENTAL AIR ABRASIVE 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.

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.

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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