Disposable Prophy Angle

FDA 510(k) K240950 · Pacific Care Limited

Substantially Equivalent

510(k) numberK240950

Submission

Device name
Disposable Prophy Angle
Applicant
Pacific Care Limited
N.T., HK
Received
April 8, 2024
Decision date
May 28, 2025
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EGS – Handpiece, Contra- And Right-Angle Attachment, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Specialty
Dental

Other 510(k)s with product code EGS

510(k)DeviceApplicantDecision
K251869Disposable Prophy Angle (3399-60, 3399-090, 3399-105)EGS · Traditional Premium Plus (Dongguan) Limited09/15/2025SE
K240183Star E900 Handpiece SeriesEGS · Traditional Dentalez, Inc., Stardental Division09/19/2024SE
K230106General Cutting StraightEGS · Traditional Nakanishi, Inc.05/24/2023SE
K222518FX ContraEGS · Traditional Nakanishi, Inc.11/17/2022SE
K220874Smooth Drive contra angle and straight handpiecesEGS · Traditional Lares Research11/07/2022SE
K220346Lotus Prophy AngleEGS · Traditional Ajk Engineering, Inc.11/07/2022SE
K220577Dental Handpiece, Model CA160, CA160L, and CA500LEGS · Traditional Micro-Nx Co., Ltd.07/29/2022SE
K213139SURGmatic S15 L ProEGS · Traditional Kavo Dental GmbH12/21/2021SE
K202960General Cutting Contra HandpieceEGS · Special Nakanishi, Inc.10/27/2020SE
K182892TRAUS Dental HandpiecesEGS · Traditional Saeshin Precision Co., Ltd.11/26/2019SE

Questions and answers

When was Disposable Prophy Angle cleared by the FDA?

Disposable Prophy Angle (K240950) received a 510(k) decision of Substantially Equivalent on May 28, 2025, 415 days after the submission was received.

What is the product code of K240950?

The FDA product code is EGS – Handpiece, Contra- And Right-Angle Attachment, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.