Cleared Traditional

K062418 - K-SPRAY, MODEL 085-2715

K062418 is an FDA 510(k) clearance for K-SPRAY, manufactured by Scican. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K062418 · Scican · Dental device
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Oct 2006
Decision
62d
Days
Class 1
Risk

K062418 is an FDA 510(k) clearance for the K-SPRAY, MODEL 085-2715. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Scican (Toronto, CA). The FDA issued a Cleared decision on October 19, 2006 after a review of 62 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 - K062418

510(k) Number K062418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2006
Decision Date October 19, 2006
Days to Decision 62 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 128d · This submission: 62d
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 K062418.
DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N
K062812 · Thunder Tiger Corp. · Nov 2006
JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU
K062740 · Jindell Medical Instruments Co., Ltd. · Nov 2006
CST61 HIGH SPEED TURBINE HANDPIECE
K063110 · Shanghai Dental Instrument Factory · Oct 2006
PRODRIVE SYSTEMS REPLACEMENT TURBINE
K062219 · Prodrive Systems, Inc. · Aug 2006
INTERPROXIMAL REDUCTION SYSTEM
K053368 · Dentsply International · Mar 2006
DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202
K052822 · Thunder Tiger Corp. · Jan 2006
K062418 · K-SPRAY, MODEL 085-2715
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