Cleared Traditional

K240183 - Star E900 Handpiece Series (FDA 510(k) Clearance)

Class I Dental device.

K240183 · Dentalez, Inc., Stardental Division · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
240d
Days
Class 1
Risk

K240183 is an FDA 510(k) clearance for the Star E900 Handpiece Series. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Dentalez, Inc., Stardental Division (Lancaster, US). The FDA issued a Cleared decision on September 19, 2024 after a review of 240 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentalez, Inc., Stardental Division devices

Submission Details

510(k) Number K240183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2024
Decision Date September 19, 2024
Days to Decision 240 days
Submission Type Traditional
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
113d slower than avg
Panel avg: 127d · This submission: 240d
Pathway characteristics
Predicate-based equivalence.

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 K240183.
Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
K251869 · Premium Plus (Dongguan) Limited · Sep 2025
Disposable Prophy Angle
K240950 · Pacific Care Limited · May 2025
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