Cleared Traditional

K242611 - Integral Dental Units (FDA 510(k) Clearance)

Class I Dental device.

K242611 · Mipont Medical Equipment Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
266d
Days
Class 1
Risk

K242611 is an FDA 510(k) clearance for the Integral Dental Units. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Mipont Medical Equipment Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on May 27, 2025 after a review of 266 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Mipont Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K242611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2024
Decision Date May 27, 2025
Days to Decision 266 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
139d slower than avg
Panel avg: 127d · This submission: 266d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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 - EIA Unit, Operative Dental

All 283
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