Cleared Traditional

K213609 - NOVA RESIN dual cure, self adhesive resin cement (FDA 510(k) Clearance)

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

K213609 · Imicryl Dis Malzemeleri Sanayi VE Ticaret AS · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
267d
Days
Class 2
Risk

K213609 is an FDA 510(k) clearance for the NOVA RESIN dual cure, self adhesive resin cement. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS (Konya, TR). The FDA issued a Cleared decision on August 9, 2022 after a review of 267 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 Imicryl Dis Malzemeleri Sanayi VE Ticaret AS devices

Submission Details

510(k) Number K213609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2021
Decision Date August 09, 2022
Days to Decision 267 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
140d slower than avg
Panel avg: 127d · This submission: 267d
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 K213609.
REGEN Bioactive Cement
K253337 · Inter-Med, Inc. · Apr 2026
Bifix Veneer LC, Bifix Veneer Try-In
K252606 · Voco GmbH · Mar 2026
iCEM Universal Plus
K254063 · Kulzer, LLC · Dec 2025
TopCEM Vigor SA Self-Adhesive Resin Cement
K252785 · Rizhao Huge Biomaterials Company, Ltd. · Dec 2025
GlasIonomer FX-LC
K252808 · Shofu Dental Corporation · Dec 2025
ZIRCONOMER P
K252165 · Shofu Dental Corporation · Oct 2025