Cleared Traditional

K231845 - Dental unit Model: Mare (FDA 510(k) Clearance)

Class I Dental device.

K231845 · Foshan Safety Medical Equipment Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
251d
Days
Class 1
Risk

K231845 is an FDA 510(k) clearance for the Dental unit Model: Mare. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Foshan Safety Medical Equipment Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on February 28, 2024 after a review of 251 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 Foshan Safety Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K231845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2023
Decision Date February 28, 2024
Days to Decision 251 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
124d slower than avg
Panel avg: 127d · This submission: 251d
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 Consultant

Qimmiq Medical Consulting Service Co., Ltd.
You Yijie

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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