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FDA 510(k)

ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE

K-Number: K921601 · 1992-06-16

Decision Date1992-06-16
Product CodeJES
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE 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 1992-06-16 under 510(k) number K921601. The device is classified under product code JES. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE?

ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE is a medical device that received FDA 510(k) clearance on 1992-06-16. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K921601.

When did ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE receive FDA 510(k) clearance?

ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE received FDA 510(k) clearance on 1992-06-16, under 510(k) number K921601.

Who is the listed applicant for ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE?

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 ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE?

The FDA product code for ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE is JES.

Related Clinical Trials

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Other records listing Ultradent Products, Inc. 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.

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Related Devices (Code: JES)

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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