Cleared Traditional

K250317 - EsFlow PLUS

K250317 is an FDA 510(k) clearance for EsFlow PLUS, manufactured by Spident Co., Ltd.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K250317 · Spident Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
115d
Days
Class 2
Risk

K250317 is an FDA 510(k) clearance for the EsFlow PLUS. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Spident Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on May 30, 2025 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 - K250317

510(k) Number K250317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2025
Decision Date May 30, 2025
Days to Decision 115 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
12d faster than avg
Panel avg: 127d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 645
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K250317.
Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)
K253053 · Hangzhou SHINING3D Dental Technology Co., Ltd. · Sep 2025
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K251946 · GC America, Inc. · Aug 2025
Once-Fil Flow
K251283 · Mediclus Co., Ltd. · Jun 2025
BEAUTIFIL II
K251578 · Shofu Dental Corporation · May 2025
Sil-Flow
K250778 · Dsi Dental Solutions, Ltd. · May 2025
GrandioSO Unlimited
K251239 · Voco GmbH · May 2025