Cleared Traditional

K163714 - OSSIX BONE

K163714 is an FDA 510(k) clearance for OSSIX BONE, manufactured by Datum Dental, Ltd.. The device is a Class 2 Dental device with product code NPM cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K163714 · Datum Dental, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
200d
Days
Class 2
Risk

K163714 is an FDA 510(k) clearance for the OSSIX BONE. Classified as Bone Grafting Material, Animal Source (product code NPM), Class II - Special Controls.

Submitted by Datum Dental, Ltd. (Lod, IL). The FDA issued a Cleared decision on July 18, 2017 after a review of 200 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.

View all Datum Dental, Ltd. devices

FDA 510(k) Submission Details - K163714

510(k) Number K163714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2016
Decision Date July 18, 2017
Days to Decision 200 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 127d · This submission: 200d
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 25
Devices cleared under the same product code (NPM) and FDA review panel - the closest regulatory comparables to K163714.
Straumann cerabone
K173594 · Institut Straumann AG · Oct 2018
The Graft Natural Bone Substitute
K173188 · Purgo Biologics, Inc. · Jul 2018
Anorganic Bone Mineral with Collagen in Delivery Applicator
K171008 · Collagen Matrix, Inc. · Oct 2017
Anorganic Bone Mineral in Delivery Applicator
K170541 · Collagen Matrix, Inc. · Jul 2017
Porcine Anorganic Bone Mineral in Delivery Applicator
K162158 · Collagen Matrix, Inc. · Feb 2017
A-Oss
K151542 · Hiossen, Inc. · Aug 2016