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FDA 510(k)

ZEROS Dental Implant System

K-Number: K260463 · 2026-08-19

Decision Date2026-08-19
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZEROS Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Zeros Co., Ltd.. It received FDA 510(k) clearance on 2026-08-19 under 510(k) number K260463. 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 ZEROS Dental Implant System?

ZEROS Dental Implant System is a medical device that received FDA 510(k) clearance on 2026-08-19. The listed applicant is Zeros Co., Ltd.. The 510(k) number is K260463.

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

ZEROS Dental Implant System received FDA 510(k) clearance on 2026-08-19, under 510(k) number K260463.

Who is the listed applicant for ZEROS Dental Implant System?

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

What is the FDA product code for ZEROS Dental Implant System?

The FDA product code for ZEROS Dental Implant System is DZE.

Other records listing Zeros 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.

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.

Official Source

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