Cleared Traditional

IR SLA Type Implant System (K222144) - FDA 510(k) Clearance

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

K222144 · Biotem Co., Ltd. · Dental device
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Jun 2023
Decision
329d
Days
Class 2
Risk

K222144 is an FDA 510(k) clearance for the IR SLA Type Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Biotem Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on June 14, 2023 after a review of 329 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 Biotem Co., Ltd. devices

Submission Details

510(k) Number K222144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2022
Decision Date June 14, 2023
Days to Decision 329 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
202d slower than avg
Panel avg: 127d · This submission: 329d
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 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 K222144.
BR SLA Type Implant System
K222142 · Biotem Co., Ltd. · Jun 2023
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K223638 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Jun 2023
Straumann SLActive labeling changes
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SNUCONE Tissue Level Implant System
K222792 · Snucone Co., Ltd. · Jun 2023
Stella
K221752 · Shinhung Mst Co., Ltd. · Jun 2023
Genesis ACTIVE Implant System
K223814 · Keystone Dental, Inc. · May 2023