Cleared Abbreviated

Disposable Prophy Angle

K240950 · Pacific Care Limited · Dental

May 2025

Decision

415d

Days

Class 1

Risk

About This 510(k) Submission

K240950 is an FDA 510(k) clearance for the Disposable Prophy Angle, a Handpiece, Contra- And Right-angle Attachment, Dental (Class I — General Controls, product code EGS), submitted by Pacific Care Limited (N.T., HK). The FDA issued a Cleared decision on May 28, 2025, 415 days after receiving the submission on April 8, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K240950 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 08, 2024
Decision Date	May 28, 2025
Days to Decision	415 days
Submission Type	Abbreviated
Review Panel	Dental (DE)
Summary	Summary PDF