Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SD Implant System

K-Number: K241703 · 2025-02-24

ApplicantArum Dentistry Co., Ltd.
Decision Date2025-02-24
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SD Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Arum Dentistry Co., Ltd.. It received FDA 510(k) clearance on 2025-02-24 under 510(k) number K241703. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SD Implant System?

SD Implant System is a medical device that received FDA 510(k) clearance on 2025-02-24. The listed applicant is Arum Dentistry Co., Ltd.. The 510(k) number is K241703.

When did SD Implant System receive FDA 510(k) clearance?

SD Implant System received FDA 510(k) clearance on 2025-02-24, under 510(k) number K241703.

Who is the listed applicant for SD Implant System?

The FDA 510(k) record lists Arum Dentistry Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SD Implant System?

The FDA product code for SD Implant System is DZE.

Other records listing Arum Dentistry Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250280SD TL Implant SystemK250063ARENA Star, Galaxy StarK242753SD TL Implant SystemK242245Customized AbutmentK232559C&B NFH HybridK240603Ti-Base & Master Fix

View all 17 devices →

Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑