Cleared Traditional

SNUCONE Tissue Level Implant System (K222792) - FDA 510(k) Clearance

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

K222792 · Snucone Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
265d
Days
Class 2
Risk

K222792 is an FDA 510(k) clearance for the SNUCONE Tissue Level Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Snucone Co., Ltd. (Dalseo-Gu, KR). The FDA issued a Cleared decision on June 8, 2023 after a review of 265 days - an extended review cycle.

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 Snucone Co., Ltd. devices

Submission Details

510(k) Number K222792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2022
Decision Date June 08, 2023
Days to Decision 265 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
138d slower than avg
Panel avg: 127d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Wise Company, Inc.
Sanglok Lee

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 - DZE Implant, Endosseous, Root-form

All 304
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K222792.
Neodent Implant System - Helix Short Implant System
K223638 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Jun 2023
Straumann SLActive labeling changes
K223083 · Institut Straumann AG · Jun 2023
IR SLA Type Implant System
K222144 · Biotem Co., Ltd. · Jun 2023
Stella
K221752 · Shinhung Mst Co., Ltd. · Jun 2023
Genesis ACTIVE Implant System
K223814 · Keystone Dental, Inc. · May 2023
Point implant system
K222738 · Pointnix Co., Ltd. · Apr 2023