Cleared Traditional

K101426 - CEROS TCP GRANULES

K101426 is an FDA 510(k) clearance for CEROS TCP GRANULES, manufactured by Mathys, Ltd.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K101426 · Mathys, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
117d
Days
Class 2
Risk

K101426 is an FDA 510(k) clearance for the CEROS TCP GRANULES. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Mathys, Ltd. (San Diego, US). The FDA issued a Cleared decision on September 15, 2010 after a review of 117 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 Mathys, Ltd. devices

FDA 510(k) Submission Details - K101426

510(k) Number K101426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2010
Decision Date September 15, 2010
Days to Decision 117 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
10d faster than avg
Panel avg: 127d · This submission: 117d
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 124
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K101426.
CARRIGEN
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VITOMATRIX
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HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025
K093390 · Depuy Spine, Inc. · May 2010
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
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