Cleared Traditional

K050984 - BIOPLANT

K050984 is an FDA 510(k) clearance for BIOPLANT, manufactured by Kerr Dental Materials Center. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K050984 · Kerr Dental Materials Center · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
114d
Days
Class 2
Risk

K050984 is an FDA 510(k) clearance for the BIOPLANT. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Kerr Dental Materials Center (Orange, US). The FDA issued a Cleared decision on August 11, 2005 after a review of 114 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 Kerr Dental Materials Center devices

FDA 510(k) Submission Details - K050984

510(k) Number K050984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2005
Decision Date August 11, 2005
Days to Decision 114 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
13d faster than avg
Panel avg: 127d · This submission: 114d
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 104
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K050984.
PERIOGLAS BONE GRAFT PARTICULATE
K053387 · Novabone Products, LLC · Feb 2006
SYNTHES (USA) CHRONOS-BETA-TCP
K053022 · Synthes (Usa) · Jan 2006
FORTOSS VITAL BONE GRAFT SUBSTITUTE
K050170 · Biocomposites, Ltd. · Aug 2005
CALC-I-OSS
K042583 · Ultradent Products, Inc. · Jul 2005
ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE
K051381 · Ace Surgical Supply Co., Inc. · Jul 2005
OSTIM
K030052 · Heraeus Kulzer, Inc. · Dec 2004