Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Dental Air Polishing Handpiece

K-Number: K221548 · 2022-09-28

Decision Date2022-09-28
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Air Polishing Handpiece 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 2022-09-28 under 510(k) number K221548. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental Air Polishing Handpiece?

Dental Air Polishing Handpiece is a medical device that received FDA 510(k) clearance on 2022-09-28. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. The 510(k) number is K221548.

When did Dental Air Polishing Handpiece receive FDA 510(k) clearance?

Dental Air Polishing Handpiece received FDA 510(k) clearance on 2022-09-28, under 510(k) number K221548.

Who is the listed applicant for Dental Air Polishing Handpiece?

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 Air Polishing Handpiece?

The FDA product code for Dental Air Polishing Handpiece is EFB.

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.

Other records listing Guilin Woodpecker Medical Instrument Co., Ltd. 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.

View all 11 devices →

Related Devices (Code: EFB)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.