Cleared Traditional

ORTHOSS RESORBABLE BONE VOID FILLER (K014289) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K014289 · Geistlich-Pharma · Dental device
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Mar 2002
Decision
90d
Days
Class 2
Risk

K014289 is an FDA 510(k) clearance for the ORTHOSS RESORBABLE BONE VOID FILLER. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Geistlich-Pharma (Washington, US). The FDA issued a Cleared decision on March 28, 2002 after a review of 90 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.

View all Geistlich-Pharma devices

Submission Details

510(k) Number K014289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2001
Decision Date March 28, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LYC Bone Grafting Material, Synthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition A Synthetic Bone Grafting Material Is Synthetically-derived Device, Such As Hydroxylapatite, Intended To Fill, Augment, Or Reconstruct Periodontal 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 - LYC Bone Grafting Material, Synthetic

All 28
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K014289.
TRICOS A RESORBABLE SUBSTITUTE
K081721 · Baxter Healthcare Corp · Aug 2008
SYNTHES (USA) CHRONOS-BETA-TCP
K053022 · Synthes (Usa) · Jan 2006
OSTIM
K030052 · Heraeus Kulzer, Inc. · Dec 2004
GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE
K013346 · W.L. Gore & Associates, Inc. · Dec 2001
MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER
K010701 · Medtronic Sofamor Danek USA, Inc. · Jun 2001
MIMIX BONE REPLACEMENT SYSTEM
K003494 · Biomet, Inc. · Apr 2001