FDA 510(k)

牙科洁牙机和喷砂机

K号: K203615 · 2021-12-10

申请人Guilin Woodpecker Medical Instrument Co., Ltd.

决定日期2021-12-10

产品代码ELC

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决定实质等同

器械摘要

Dental Scaler and Air Polisher 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 2021-12-10 under 510(k) number K203615. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Dental Scaler and Air Polisher?

Dental Scaler and Air Polisher is a medical device that received FDA 510(k) clearance on 2021-12-10. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. The 510(k) number is K203615.

When did Dental Scaler and Air Polisher receive FDA 510(k) clearance?

Dental Scaler and Air Polisher received FDA 510(k) clearance on 2021-12-10, under 510(k) number K203615.

Who is the listed applicant for Dental Scaler and Air Polisher?

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 Dental Scaler and Air Polisher?

The FDA product code for Dental Scaler and Air Polisher is ELC.