Cleared Traditional

K090950 - BONE PLUS BCP

K090950 is an FDA 510(k) clearance for BONE PLUS BCP, manufactured by Megagen Implant Co., Ltd.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 455-day FDA review.

K090950 · Megagen Implant Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
455d
Days
Class 2
Risk

K090950 is an FDA 510(k) clearance for the BONE PLUS BCP. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Megagen Implant Co., Ltd. (Santa Fe Springs, US). The FDA issued a Cleared decision on July 2, 2010 after a review of 455 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

FDA 510(k) Submission Details - K090950

510(k) Number K090950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2009
Decision Date July 02, 2010
Days to Decision 455 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
327d slower than avg
Panel avg: 128d · This submission: 455d
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 230
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K090950.
BOND BONE
K101014 · Mis Implants Technologies , Ltd. · Oct 2010
VITOMATRIX
K091618 · Orthovita, Inc. · Sep 2010
CEROS TCP GRANULES
K101426 · Mathys, Ltd. · Sep 2010
POLYBONE DENTAL
K092194 · Kyung Won Medical Co., Ltd. · Jun 2010
HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025
K093390 · Depuy Spine, Inc. · May 2010
PERIOPHIL B-TCP
K093871 · Cytophil, Inc. · Apr 2010
K090950 · BONE PLUS BCP
Download PDF FDA Summary Megagen Implant Co., …