Cleared Traditional

K242366 - OverCEM SA Universal

Also marketed or referenced as:
OverCEM SA Translucent OverCEM SA Opaque OverCEM Ti-Abutment OverCEM Cer-Abutment

K242366 is an FDA 510(k) clearance for OverCEM SA Universal, manufactured by Overfibers S.R.L.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K242366 · Overfibers S.R.L. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
154d
Days
Class 2
Risk

K242366 is an FDA 510(k) clearance for the OverCEM SA Universal. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Overfibers S.R.L. (Imola (Bo), IT). The FDA issued a Cleared decision on January 10, 2025 after a review of 154 days - an extended review cycle.

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 Overfibers S.R.L. devices

FDA 510(k) Submission Details - K242366

510(k) Number K242366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2024
Decision Date January 10, 2025
Days to Decision 154 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
27d slower than avg
Panel avg: 127d · This submission: 154d
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 331
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K242366.
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