Cleared Abbreviated

K240950 - Disposable Prophy Angle (FDA 510(k) Clearance)

Class I Dental device.

K240950 · Pacific Care Limited · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
415d
Days
Class 1
Risk

K240950 is an FDA 510(k) clearance for the Disposable Prophy Angle. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Pacific Care Limited (N.T., HK). The FDA issued a Cleared decision on May 28, 2025 after a review of 415 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Pacific Care Limited devices

Submission Details

510(k) Number K240950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
288d slower than avg
Panel avg: 127d · This submission: 415d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code EGS Handpiece, Contra- And Right-angle Attachment, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EGS Handpiece, Contra- And Right-angle Attachment, Dental

All 72
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K240950.
Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
K251869 · Premium Plus (Dongguan) Limited · Sep 2025
Star E900 Handpiece Series
K240183 · Dentalez, Inc., Stardental Division · Sep 2024
General Cutting Straight
K230106 · Nakanishi, Inc. · May 2023
FX Contra
K222518 · Nakanishi, Inc. · Nov 2022
Lotus Prophy Angle
K220346 · Ajk Engineering, Inc. · Nov 2022
Smooth Drive contra angle and straight handpieces
K220874 · Lares Research · Nov 2022