Cleared Traditional

K250566 - EsCem RMGI

K250566 is an FDA 510(k) clearance for EsCem RMGI, manufactured by Spident Co., Ltd.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 114-day FDA review.

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

FDA 510(k) Submission Details - K250566

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.

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 309
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