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FDA 510(k)

MODIFICATION OF PQ1

K-Number: K983668 · 1998-11-30

ApplicantUltradent Products, Inc.
Decision Date1998-11-30
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF PQ1 is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 1998-11-30 under 510(k) number K983668. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION OF PQ1?

MODIFICATION OF PQ1 is a medical device that received FDA 510(k) clearance on 1998-11-30. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K983668.

When did MODIFICATION OF PQ1 receive FDA 510(k) clearance?

MODIFICATION OF PQ1 received FDA 510(k) clearance on 1998-11-30, under 510(k) number K983668.

Who is the listed applicant for MODIFICATION OF PQ1?

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

What is the FDA product code for MODIFICATION OF PQ1?

The FDA product code for MODIFICATION OF PQ1 is KLE.

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Other records listing Ultradent Products, Inc. as applicant

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Related Devices (Code: KLE)

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

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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