Cleared Traditional

K261295 - MultiNeO Dental Implant System

K261295 is an FDA 510(k) clearance for MultiNeO Dental Implant System, manufactured by Alpha-Bio Tec , Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K261295 · Alpha-Bio Tec , Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
185d
Days
Class 2
Risk

K261295 is an FDA 510(k) clearance for the MultiNeO Dental Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Alpha-Bio Tec , Ltd. (Modi'In, IL). The FDA issued a Cleared decision on October 22, 2026 after a review of 185 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.

FDA 510(k) Submission Details - K261295

510(k) Number K261295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2026
Decision Date October 22, 2026
Days to Decision 185 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
57d slower than avg
Panel avg: 128d · This submission: 185d
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 1549
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K261295.
TriActive Dental Implant System
K261392 · Paragon Implant Mfg., LLC · Sep 2026
ZEROS Dental Implant System
K260463 · Zeros Co., Ltd. · Aug 2026
UNIQA® Dental Implants System
K251188 · Uniqa Dental, Ltd. · Jun 2026
Dental Implant System
K250806 · A.B. Dental Devices , Ltd. · Jun 2026
MegaGen Zygoma Dental Implant System
K251232 · Megagen Implant Co., Ltd. · Jun 2026
INOSS System
K260006 · Inosys, Inc. · Jun 2026
K261295 · MultiNeO Dental Implant System
Download PDF FDA Summary Alpha-Bio Tec , Ltd.