Cleared Traditional

K221752 - Stella

K221752 is an FDA 510(k) clearance for Stella, manufactured by Shinhung Mst Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 353-day FDA review.

K221752 · Shinhung Mst Co., Ltd. · Dental device
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Optimized for regulatory review, auditing and printing
Jun 2023
Decision
353d
Days
Class 2
Risk

K221752 is an FDA 510(k) clearance for the Stella. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Shinhung Mst Co., Ltd. (Wonju-Si, KR). The FDA issued a Cleared decision on June 4, 2023 after a review of 353 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Shinhung Mst Co., Ltd. devices

FDA 510(k) Submission Details - K221752

510(k) Number K221752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2022
Decision Date June 04, 2023
Days to Decision 353 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
226d slower than avg
Panel avg: 127d · This submission: 353d
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.

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All 765
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