Cleared Traditional

K260096 - Wishbone HAE

K260096 is an FDA 510(k) clearance for Wishbone HAE, manufactured by Wishbone SA. The device is a Class 2 Dental device with product code NPM cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K260096 · Wishbone SA · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
269d
Days
Class 2
Risk

K260096 is an FDA 510(k) clearance for the Wishbone HAE. Classified as Bone Grafting Material, Animal Source (product code NPM), Class II - Special Controls.

Submitted by Wishbone SA (Flémalle, BE). The FDA issued a Cleared decision on October 9, 2026 after a review of 269 days - an extended review cycle.

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 - K260096

510(k) Number K260096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2026
Decision Date October 09, 2026
Days to Decision 269 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
141d slower than avg
Panel avg: 128d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NPM Device Classification - Class 2, Special Controls

Product Code NPM Bone Grafting Material, Animal Source
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition A Animal-source Bone Grafting Material Is A Naturally-derived Device, Such As Collagen, Intended To Fill, Augment, Or Reconstruct Periodontal Defects And Or Bony Defects Of The Upper Or Lower Jaw.
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 - NPM Bone Grafting Material, Animal Source

All 41
Devices cleared under the same product code (NPM) and FDA review panel - the closest regulatory comparables to K260096.
REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)
K254210 · Hyundai Bioland Co., Ltd. · Sep 2026
BOSS
K253723 · Medpark Co., Ltd. · Jun 2026
Geistlich Bio-Oss®
K251786 · Geistlich Pharma AG · Jul 2025
SwissGraft X
K251613 · Geistlich Pharma AG · Jun 2025
Geistlich Bio-Flow®
K242510 · Geistlich Pharma AG · Mar 2025
Xenograft Bovine Bone Particulate
K240133 · Collagen Solutions, LLC · Aug 2024
K260096 · Wishbone HAE
Download PDF FDA Summary Wishbone SA