Cleared Traditional

K052470 - F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT

K052470 is an FDA 510(k) clearance for F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT, manufactured by Shanghai Fimet Medical Instrument Co., Ltd.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K052470 · Shanghai Fimet Medical Instrument Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
54d
Days
Class 1
Risk

K052470 is an FDA 510(k) clearance for the F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Shanghai Fimet Medical Instrument Co., Ltd. (Deer Field, US). The FDA issued a Cleared decision on November 1, 2005 after a review of 54 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shanghai Fimet Medical Instrument Co., Ltd. devices

FDA 510(k) Submission Details - K052470

510(k) Number K052470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2005
Decision Date November 01, 2005
Days to Decision 54 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
73d faster than avg
Panel avg: 127d · This submission: 54d
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 Peers - EIA Unit, Operative Dental

All 154
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