Cleared Traditional

K970626 - EASY CAM

K970626 is an FDA 510(k) clearance for EASY CAM, manufactured by I.C.S.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K970626 · I.C.S. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
44d
Days
Class 1
Risk

K970626 is an FDA 510(k) clearance for the EASY CAM. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by I.C.S. (San Diego, US). The FDA issued a Cleared decision on April 4, 1997 after a review of 44 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 I.C.S. devices

FDA 510(k) Submission Details - K970626

510(k) Number K970626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1997
Decision Date April 04, 1997
Days to Decision 44 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
83d faster than avg
Panel avg: 127d · This submission: 44d
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 109
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K970626.
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PROSTYLE COMPACT
K961420 · Planmeca Oy · Sep 1996