Cleared Traditional

K161774 - i-Sil

K161774 is an FDA 510(k) clearance for i-Sil, manufactured by Spident Co., Ltd.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K161774 · Spident Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
94d
Days
Class 2
Risk

K161774 is an FDA 510(k) clearance for the i-Sil. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Spident Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on September 30, 2016 after a review of 94 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 Spident Co., Ltd. devices

FDA 510(k) Submission Details - K161774

510(k) Number K161774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2016
Decision Date September 30, 2016
Days to Decision 94 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
34d faster than avg
Panel avg: 128d · This submission: 94d
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 Consultant

Spident USA, Inc.
Mark Choi

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ELW Material, Impression

All 341
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K161774.
HygePLUS Alginate Impression Material
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HySil Impression Materials
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Vonflex S
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Image Fast Set, Image Regular Set
K160097 · Sybron Dental Specialties · Aug 2016
Identic and KromaFaze Alginate Dental Impression Materials
K160441 · Kerr Corporation · Jun 2016
NoCord
K152826 · Centrix, Inc. · May 2016