Cleared Traditional

K222144 - IR SLA Type Implant System

K222144 is an FDA 510(k) clearance for IR SLA Type Implant System, manufactured by Biotem Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 329-day FDA review.

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

FDA 510(k) Submission Details - K222144

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.

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 Peers - DZE Implant, Endosseous, Root-form

All 765
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