Cleared Traditional

K102872 - OSBONE DENTAL

K102872 is an FDA 510(k) clearance for OSBONE DENTAL, manufactured by Curasan AG. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K102872 · Curasan AG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
104d
Days
Class 2
Risk

K102872 is an FDA 510(k) clearance for the OSBONE DENTAL. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Curasan AG (North Attleboro, US). The FDA issued a Cleared decision on January 12, 2011 after a review of 104 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 - K102872

510(k) Number K102872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2010
Decision Date January 12, 2011
Days to Decision 104 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
24d faster than avg
Panel avg: 128d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LYC Device Classification - Class 2, Special Controls

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 230
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K102872.
NANOGEN
K102208 · Orthogen, LLC · May 2011
OSTEOSCAF
K101827 · Texas Innovative Medical Devices (Dba) Skeletal · Apr 2011
CERACELL DENTAL
K103709 · Curasan AG · Mar 2011
CARRIGEN
K100883 · Etex Corp. · Dec 2010
GAMMA-BSM
K102812 · Etex Corporation · Dec 2010
OSTEON, OSTEON SINUS, OSTEON LIFTING
K102015 · Genoss Co., Ltd. · Nov 2010
K102872 · OSBONE DENTAL
Download PDF FDA Summary Curasan AG