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FDA 510(k)

ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L

K-Number: K053555 · 2006-08-21

ApplicantGuilin Woodpecker Medical Instrument Co., Ltd.
Decision Date2006-08-21
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2006-08-21 under 510(k) number K053555. 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 ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L?

ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L is a medical device that received FDA 510(k) clearance on 2006-08-21. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. The 510(k) number is K053555.

When did ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L receive FDA 510(k) clearance?

ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L received FDA 510(k) clearance on 2006-08-21, under 510(k) number K053555.

Who is the listed applicant for ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L?

The FDA 510(k) record lists Guilin Woodpecker Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L?

The FDA product code for ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L is ELC.

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Related Devices (Code: ELC)

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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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