Cleared Traditional

K251470 - ResiCem EX (FDA 510(k) Clearance)

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

K251470 · Shofu Dental Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
59d
Days
Class 2
Risk

K251470 is an FDA 510(k) clearance for the ResiCem EX. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on July 11, 2025 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shofu Dental Corporation devices

Submission Details

510(k) Number K251470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2025
Decision Date July 11, 2025
Days to Decision 59 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 127d · This submission: 59d
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 K251470.
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