Cleared Traditional

K242366 - OverCEM SA Universal (FDA 510(k) Clearance)

Also includes:
OverCEM SA Translucent OverCEM SA Opaque OverCEM Ti-Abutment OverCEM Cer-Abutment

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 503
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K242366.
REGEN Bioactive Cement
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K254063 · Kulzer, LLC · Dec 2025
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ZIRCONOMER P
K252165 · Shofu Dental Corporation · Oct 2025