Cleared Traditional

K062102 - ODONCER

K062102 is an FDA 510(k) clearance for ODONCER, manufactured by Teknimed, S.A.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K062102 · Teknimed, S.A. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
266d
Days
Class 2
Risk

K062102 is an FDA 510(k) clearance for the ODONCER. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Teknimed, S.A. (Round Rock, US). The FDA issued a Cleared decision on April 16, 2007 after a review of 266 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 Teknimed, S.A. devices

FDA 510(k) Submission Details - K062102

510(k) Number K062102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2006
Decision Date April 16, 2007
Days to Decision 266 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
139d slower than avg
Panel avg: 127d · This submission: 266d
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 K062102.
OSTEOGRAF/D-700
K072056 · Dentsply International, Inc. · Aug 2007
OSTEOGRAF/LD-300
K072057 · Dentsply International, Inc. · Aug 2007
OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050
K062834 · Genoss Co., Ltd. · Apr 2007
PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL
K063596 · Novabone Products, LLC · Feb 2007
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
K063549 · Novabone Products, LLC · Feb 2007
PERIOGLAS BONE GRAFT PARTICULATE
K053387 · Novabone Products, LLC · Feb 2006