Cleared Traditional

K262415 - OSSIX Plus

K262415 is an FDA 510(k) clearance for OSSIX Plus, manufactured by Datum Dental, Ltd.. The device is a Class 2 Dental device with product code NPL cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K262415 · Datum Dental, Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
106d
Days
Class 2
Risk

K262415 is an FDA 510(k) clearance for the OSSIX Plus. Classified as Barrier, Animal Source, Intraoral (product code NPL), Class II - Special Controls.

Submitted by Datum Dental, Ltd. (Yavne Centra, IL). The FDA issued a Cleared decision on October 29, 2026 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - 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 - K262415

510(k) Number K262415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2026
Decision Date October 29, 2026
Days to Decision 106 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
22d faster than avg
Panel avg: 128d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NPL Device Classification - Class 2, Special Controls

Product Code NPL Barrier, Animal Source, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition An Animal Source Dental Barrier Is An Animal-derived Material Device, Such As Collagen, Intended To Aid In Guided Tissue/bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials When Placed Around Implants.
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 Consultant

Hogan Lovells US Llp
Kelliann Payne

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NPL Barrier, Animal Source, Intraoral

All 57
Devices cleared under the same product code (NPL) and FDA review panel - the closest regulatory comparables to K262415.
Jason membrane
K242817 · Botiss Biomaterials GmbH · Dec 2025
Augmented Gingival Matrix
K250512 · Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. · Dec 2025
Geistlich Mucograft® /Geistlich Mucograft® Seal
K252253 · Geistlich Pharma AG · Nov 2025
Geistlich Bio-Gide
K251062 · Geistlich Pharma AG · Aug 2025
SwissMembrane X
K250833 · Geistlich Pharma AG · Apr 2025
Soft Tissue Augmentation Resorbable Matrix
K233203 · Collagen Matrix, Inc. · May 2024
K262415 · OSSIX Plus
Download PDF FDA Summary Datum Dental, Ltd.