Cleared Traditional

K213599 - SuperLine

K213599 is an FDA 510(k) clearance for SuperLine, manufactured by Dentium Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K213599 · Dentium Co., Ltd. · Dental device
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Feb 2022
Decision
100d
Days
Class 2
Risk

K213599 is an FDA 510(k) clearance for the SuperLine. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Dentium Co., Ltd. (Suwon-Si, KR). The FDA issued a Cleared decision on February 23, 2022 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 872.3640 - 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 Dentium Co., Ltd. devices

FDA 510(k) Submission Details - K213599

510(k) Number K213599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2021
Decision Date February 23, 2022
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.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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

PaxMed International, LLC
Kevin A Thomas

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.

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