Cleared Traditional

BLUE SKY BIO TCP (K110198) - FDA 510(k) Clearance

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

K110198 · Blue Sky Bio, LLC · Dental device
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Optimized for regulatory review, auditing and printing
Dec 2011
Decision
332d
Days
Class 2
Risk

K110198 is an FDA 510(k) clearance for the BLUE SKY BIO TCP. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Blue Sky Bio, LLC (Grayslake, US). The FDA issued a Cleared decision on December 22, 2011 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Blue Sky Bio, LLC devices

Submission Details

510(k) Number K110198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2011
Decision Date December 22, 2011
Days to Decision 332 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
205d slower than avg
Panel avg: 127d · This submission: 332d
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 K110198.
Straumann BoneCeramic
K201051 · Institut Straumann AG · Sep 2020
Cytrans Granules
K192597 · GC America, Inc. · Aug 2020
MASTERGRAFT PUTTY
K140374 · Medtronic Sofamor Danek USA, Inc. · Jun 2014
MEDTRONIC DENTAL TCP
K092087 · Medtronic Sofamor Danek USA, Inc. · Dec 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082917 · Medtronic Sofamor Danek · Jan 2009
MASTERGRAFT PUTTY
K081784 · Medtronic Sofamor Danek · Sep 2008