Cleared Abbreviated

K062897 - C-U2

K062897 is an FDA 510(k) clearance for C-U2, manufactured by Cefla S.C.R.L.. The device is a Class 1 Dental device with product code EIA cleared through the Abbreviated 510(k) pathway after a 78-day FDA review.

K062897 · Cefla S.C.R.L. · Dental device
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Dec 2006
Decision
78d
Days
Class 1
Risk

K062897 is an FDA 510(k) clearance for the C-U2. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Cefla S.C.R.L. (Ormond Beach, US). The FDA issued a Cleared decision on December 14, 2006 after a review of 78 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K062897

510(k) Number K062897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2006
Decision Date December 14, 2006
Days to Decision 78 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 128d · This submission: 78d
Pathway characteristics
Standards-based clearance path.

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 261
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K062897 · C-U2
Download PDF Cefla S.C.R.L.