Dental Scaler and Air Polisher
K-Number: K203615 · 2021-12-10
Decision Date2021-12-10
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Dental Scaler and Air Polisher is a medical device manufactured by Guilin Woodpecker Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2021-12-10 under approval number K203615. 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 Dental Scaler and Air Polisher?
Dental Scaler and Air Polisher is a medical device that received FDA 510(k) clearance on 2021-12-10. It is manufactured by Guilin Woodpecker Medical Instrument Co., Ltd.. The 510(k) number is K203615.
When was Dental Scaler and Air Polisher approved by the FDA?
Dental Scaler and Air Polisher received FDA 510(k) clearance on 2021-12-10, under approval number K203615.
What company makes Dental Scaler and Air Polisher?
Dental Scaler and Air Polisher is manufactured by Guilin Woodpecker Medical Instrument Co., Ltd..
What is the FDA product code for Dental Scaler and Air Polisher?
The FDA product code for Dental Scaler and Air Polisher is ELC.
Other Devices by Guilin Woodpecker Medical Instrument Co., Ltd.
Related Devices (Code: ELC)
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.