Cleared Traditional

K241703 - SD Implant System

K241703 is an FDA 510(k) clearance for SD Implant System, manufactured by Arum Dentistry Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K241703 · Arum Dentistry Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
256d
Days
Class 2
Risk

K241703 is an FDA 510(k) clearance for the SD Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Arum Dentistry Co., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on February 24, 2025 after a review of 256 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 Arum Dentistry Co., Ltd. devices

FDA 510(k) Submission Details - K241703

510(k) Number K241703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2024
Decision Date February 24, 2025
Days to Decision 256 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
129d slower than avg
Panel avg: 127d · This submission: 256d
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 758
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K241703.
CeraRoot TL Implant System (TL)
K242072 · Ceraroot SL · May 2025
OsseOne Dental Implant System
K233271 · Synoross Dba Osseone · May 2025
DAND Dental Implant System
K250176 · D.A.N.D. Metal Industries North, Ltd. · Apr 2025
LONGY Implant and LONGY-N Implant
K241462 · Noris Medical , Ltd. · Feb 2025
Surcam Dental Implant System
K242217 · Surcam Medical Devices and Developments, Ltd. · Jan 2025
TRI-matrix® X-Force Implants
K242661 · Tri Dental Implants Int. AG · Jan 2025