Cleared Traditional

K071353 - FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C

K071353 is an FDA 510(k) clearance for FOSHION CHAIR MOUNTED DENTAL, manufactured by Shanghai Foshion Medical Instruments Co., Ltd.. The device is a Class 1 Dental device with product code KLC cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K071353 · Shanghai Foshion Medical Instruments Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
213d
Days
Class 1
Risk

K071353 is an FDA 510(k) clearance for the FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C. Classified as Chair, Dental, With Operative Unit (product code KLC), Class I - General Controls.

Submitted by Shanghai Foshion Medical Instruments Co., Ltd. (Leola, US). The FDA issued a Cleared decision on December 14, 2007 after a review of 213 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6250 - 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 Shanghai Foshion Medical Instruments Co., Ltd. devices

FDA 510(k) Submission Details - K071353

510(k) Number K071353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2007
Decision Date December 14, 2007
Days to Decision 213 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 127d · This submission: 213d
Pathway characteristics
Predicate-based equivalence.

KLC Device Classification - Class 1, General Controls

Product Code KLC Chair, Dental, With Operative Unit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6250
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 - KLC Chair, Dental, With Operative Unit

All 28
Devices cleared under the same product code (KLC) and FDA review panel - the closest regulatory comparables to K071353.
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