Cleared Traditional

EsCem RMGI (K250566) - FDA 510(k) Clearance

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

K250566 · Spident Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
114d
Days
Class 2
Risk

K250566 is an FDA 510(k) clearance for the EsCem RMGI. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Spident Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on June 20, 2025 after a review of 114 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 Spident Co., Ltd. devices

Submission Details

510(k) Number K250566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2025
Decision Date June 20, 2025
Days to Decision 114 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
13d faster than avg
Panel avg: 127d · This submission: 114d
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 135
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K250566.
RODIN Cement
K251775 · Belport Company, Inc., Gingi-Pak · Sep 2025
Choice 2 DC
K250156 · Bisco, Inc. · Jul 2025
ResiCem EX
K251470 · Shofu Dental Corporation · Jul 2025
OverCEM SA Universal
K242366 · Overfibers S.R.L. · Jan 2025
Insure® Universal
K240714 · Cosmedent, Inc. · Jul 2024
TopCEM-Veneer Light Cure Veneer Cement
K241204 · Rizhao Huge Biomaterials Company, Ltd. · Jun 2024