Cleared Traditional

PEAK NS033CF, PEAK NS017CF (K180565) - FDA 510(k) Clearance

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

K180565 · Neosil Co., Ltd. · Dental device
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Optimized for regulatory review, auditing and printing
Jun 2018
Decision
100d
Days
Class 2
Risk

K180565 is an FDA 510(k) clearance for the PEAK NS033CF, PEAK NS017CF. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Neosil Co., Ltd. (Gyeongsangnam-Do, KR). The FDA issued a Cleared decision on June 13, 2018 after a review of 100 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 Neosil Co., Ltd. devices

Submission Details

510(k) Number K180565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2018
Decision Date June 13, 2018
Days to Decision 100 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
27d faster than avg
Panel avg: 127d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Onbix Corporation
Yang Ho Dong

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 93
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K180565.
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GC BLUE SILICONE
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FIT CHECKER ADVANCED
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