Cleared Special

K260463 - ZEROS Dental Implant System

K260463 is an FDA 510(k) clearance for ZEROS Dental Implant System, manufactured by Zeros Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 188-day FDA review.

K260463 · Zeros Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
188d
Days
Class 2
Risk

K260463 is an FDA 510(k) clearance for the ZEROS Dental Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Zeros Co., Ltd. (Gyeongsangnam-Do, KR). The FDA issued a Cleared decision on August 19, 2026 after a review of 188 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K260463

510(k) Number K260463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2026
Decision Date August 19, 2026
Days to Decision 188 days
Submission Type Special
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
60d slower than avg
Panel avg: 128d · This submission: 188d
Pathway characteristics
Modification to existing cleared device.

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 1549
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K260463.
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K260463 · ZEROS Dental Implant System
Download PDF FDA Summary Zeros Co., Ltd.