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)

Disposable Prophy Angle

K-Number: K240950 · 2025-05-28

ApplicantPacific Care Limited
Decision Date2025-05-28
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Disposable Prophy Angle is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Care Limited. It received FDA 510(k) clearance on 2025-05-28 under 510(k) number K240950. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Prophy Angle?

Disposable Prophy Angle is a medical device that received FDA 510(k) clearance on 2025-05-28. The listed applicant is Pacific Care Limited. The 510(k) number is K240950.

When did Disposable Prophy Angle receive FDA 510(k) clearance?

Disposable Prophy Angle received FDA 510(k) clearance on 2025-05-28, under 510(k) number K240950.

Who is the listed applicant for Disposable Prophy Angle?

The FDA 510(k) record lists Pacific Care Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Prophy Angle?

The FDA product code for Disposable Prophy Angle is EGS.

Related Devices (Code: EGS)

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.

K251869Disposable Prophy Angle (3399-60, 3399-090, 3399-105)Premium Plus (Dongguan) LimitedK240183Star E900 Handpiece SeriesDentalez, Inc., Stardental DivisionK230106General Cutting StraightNakanishi, Inc.K222518FX ContraNakanishi, Inc.K220874Smooth Drive contra angle and straight handpiecesLares ResearchK220346Lotus Prophy AngleAjk Engineering, Inc.

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.

↑