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FDA 510(k)

USI DENTAL SCALER, 25XXX SERIES

K-Number: K062791 · 2006-12-11

Decision Date2006-12-11
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

USI DENTAL SCALER, 25XXX SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Ultrasonic Services, Inc.. It received FDA 510(k) clearance on 2006-12-11 under 510(k) number K062791. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the USI DENTAL SCALER, 25XXX SERIES?

USI DENTAL SCALER, 25XXX SERIES is a medical device that received FDA 510(k) clearance on 2006-12-11. The listed applicant is Ultrasonic Services, Inc.. The 510(k) number is K062791.

When did USI DENTAL SCALER, 25XXX SERIES receive FDA 510(k) clearance?

USI DENTAL SCALER, 25XXX SERIES received FDA 510(k) clearance on 2006-12-11, under 510(k) number K062791.

Who is the listed applicant for USI DENTAL SCALER, 25XXX SERIES?

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

What is the FDA product code for USI DENTAL SCALER, 25XXX SERIES?

The FDA product code for USI DENTAL SCALER, 25XXX SERIES is ELC.

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: ELC)

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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