Cleared Traditional

K143382 - DentiAnn Smart Sil

K143382 is an FDA 510(k) clearance for DentiAnn Smart Sil, manufactured by Seilglobal Co., Ltd.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K143382 · Seilglobal Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
90d
Days
Class 2
Risk

K143382 is an FDA 510(k) clearance for the DentiAnn Smart Sil. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Seilglobal Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on February 23, 2015 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 Seilglobal Co., Ltd. devices

FDA 510(k) Submission Details - K143382

510(k) Number K143382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2014
Decision Date February 23, 2015
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 238
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