Cleared Traditional

K103820 - REPROBONE DENTAL GRAFTING MATERIAL

K103820 is an FDA 510(k) clearance for REPROBONE DENTAL GRAFTING MATERIAL, manufactured by Ceramisys, Ltd.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K103820 · Ceramisys, Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
308d
Days
Class 2
Risk

K103820 is an FDA 510(k) clearance for the REPROBONE DENTAL GRAFTING MATERIAL. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Ceramisys, Ltd. (Centercille, US). The FDA issued a Cleared decision on November 3, 2011 after a review of 308 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.

FDA 510(k) Submission Details - K103820

510(k) Number K103820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2010
Decision Date November 03, 2011
Days to Decision 308 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
180d slower than avg
Panel avg: 128d · This submission: 308d
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 208
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K103820.
BLUE SKY BIO TCP
K110198 · Blue Sky Bio, LLC · Dec 2011
NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT
K112428 · Novabone Products, LLC · Dec 2011
FOUNDATION
K111087 · Olympus Terumo Biomaterials Corporation · Nov 2011
ENDOBON XENOGRAFT GRANULES
K110449 · Biomet 3i · May 2011
NANOGEN
K102208 · Orthogen, LLC · May 2011
OSTEOSCAF
K101827 · Texas Innovative Medical Devices (Dba) Skeletal · Apr 2011
K103820 · REPROBONE DENTAL GRAFTING MATERIAL
Download PDF FDA Summary Ceramisys, Ltd.