Cleared Traditional

K260275 - Mobile Dental Solution (Model: DS50, DS70, DS90)

K260275 is an FDA 510(k) clearance for Mobile Dental Solution (Model: DS50, manufactured by Guangdong Jinme Medical Technology Co., Ltd.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K260275 · Guangdong Jinme Medical Technology Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
267d
Days
Class 1
Risk

K260275 is an FDA 510(k) clearance for the Mobile Dental Solution (Model: DS50, DS70, DS90). Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Guangdong Jinme Medical Technology Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on October 23, 2026 after a review of 267 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.

FDA 510(k) Submission Details - K260275

510(k) Number K260275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2026
Decision Date October 23, 2026
Days to Decision 267 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: 128d · This submission: 267d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

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

Guangzhou GLOMED Biological Technology Co., Ltd.
Cassie Lee

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.

Regulatory Peers - EIA Unit, Operative Dental

All 284
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K260275 · Mobile Dental Solution (Model: DS50, DS70, DS90)
Download PDF FDA Summary Guangdong Jinme Medic…