Cleared Traditional

K111087 - FOUNDATION

K111087 is an FDA 510(k) clearance for FOUNDATION, manufactured by Olympus Terumo Biomaterials Corporation. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K111087 · Olympus Terumo Biomaterials Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
224d
Days
Class 2
Risk

K111087 is an FDA 510(k) clearance for the FOUNDATION. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Olympus Terumo Biomaterials Corporation (Chevy Chase, US). The FDA issued a Cleared decision on November 29, 2011 after a review of 224 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 Olympus Terumo Biomaterials Corporation devices

FDA 510(k) Submission Details - K111087

510(k) Number K111087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2011
Decision Date November 29, 2011
Days to Decision 224 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
97d slower than avg
Panel avg: 127d · This submission: 224d
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 122
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K111087.
OSTEON II
K112716 · Genoss Co., Ltd. · Jan 2012
BLUE SKY BIO TCP
K110198 · Blue Sky Bio, LLC · Dec 2011
NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT
K112428 · Novabone Products, LLC · Dec 2011
CARRIGEN
K100883 · Etex Corp. · Dec 2010
OSTEON, OSTEON SINUS, OSTEON LIFTING
K102015 · Genoss Co., Ltd. · Nov 2010
VITOMATRIX
K091618 · Orthovita, Inc. · Sep 2010