ZEROS Dental Implant System

FDA 510(k) K260463 · Zeros Co., Ltd.

Substantially Equivalent

510(k) numberK260463

Submission

Device name
ZEROS Dental Implant System
Applicant
Zeros Co., Ltd.
Gyeongsangnam-Do, KR
Received
February 12, 2026
Decision date
August 19, 2026
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DZE – Implant, Endosseous, Root-Form
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3640
Specialty
Dental
Implant
Yes

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K252197Nobel Biocare S Series ImplantsDZE · Traditional Nobel Biocare AB02/18/2026SE

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Questions and answers

When was ZEROS Dental Implant System cleared by the FDA?

ZEROS Dental Implant System (K260463) received a 510(k) decision of Substantially Equivalent on August 19, 2026, 188 days after the submission was received.

What is the product code of K260463?

The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.