Cleared Traditional

K062355 - ENA CEM

K062355 is an FDA 510(k) clearance for ENA CEM, manufactured by Micerium S.P.A.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K062355 · Micerium S.P.A. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
135d
Days
Class 2
Risk

K062355 is an FDA 510(k) clearance for the ENA CEM. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Micerium S.P.A. (Avegno, Genoa, IT). The FDA issued a Cleared decision on December 27, 2006 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Micerium S.P.A. devices

FDA 510(k) Submission Details - K062355

510(k) Number K062355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2006
Decision Date December 27, 2006
Days to Decision 135 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
8d slower than avg
Panel avg: 127d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EMA Cement, Dental

All 382
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