Cleared Traditional

K062740 - JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU

K062740 is an FDA 510(k) clearance for JINDELL HIGH SPPED AIR TURBINE HANDPIECE, manufactured by Jindell Medical Instruments Co., Ltd.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K062740 · Jindell Medical Instruments Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
50d
Days
Class 1
Risk

K062740 is an FDA 510(k) clearance for the JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Jindell Medical Instruments Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on November 2, 2006 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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.

FDA 510(k) Submission Details - K062740

510(k) Number K062740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2006
Decision Date November 02, 2006
Days to Decision 50 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
78d faster than avg
Panel avg: 128d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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 - EFB Handpiece, Air-powered, Dental

All 247
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K062740.
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K062740 · JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU
Download PDF FDA Summary Jindell Medical Instr…