Cleared Traditional

K240183 - Star E900 Handpiece Series

K240183 is an FDA 510(k) clearance for Star E900 Handpiece Series, manufactured by Dentalez, Inc., Stardental Division. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 240-day FDA review.

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

FDA 510(k) Submission Details - K240183

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.

EGS Device Classification - Class 1, General Controls

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 19
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K240183.
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General Cutting Straight
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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