Cleared Special

K000149 - NOVABONE-BIOGLASS BONE GRAFT PARTICULATE

K000149 is an FDA 510(k) clearance for NOVABONE-BIOGLASS BONE GRAFT PARTICULATE, manufactured by Usbiomaterials Corp.. The device is a Class 2 Dental device with product code LYC cleared through the Special 510(k) pathway after a 19-day FDA review.

K000149 · Usbiomaterials Corp. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
19d
Days
Class 2
Risk

K000149 is an FDA 510(k) clearance for the NOVABONE-BIOGLASS BONE GRAFT PARTICULATE. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Usbiomaterials Corp. (Alachua, US). The FDA issued a Cleared decision on February 7, 2000 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K000149

510(k) Number K000149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2000
Decision Date February 07, 2000
Days to Decision 19 days
Submission Type Special
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
109d faster than avg
Panel avg: 128d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

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 226
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K000149.
BIO-BLOCKS
K970569 · Geistlich-Pharma · Aug 2000
SYNTHETIC GLASS BONE GRAFT MATERIAL
K000633 · Blue Sky Bio · May 2000
CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250
K993610 · Osteogenics Biomedical, Inc. · Mar 2000
UNIGRAFT
K993784 · Unicare Biomedical · Jan 2000
FORTOSS-CEMA
K993238 · Biocomposites, Ltd. · Jan 2000
OSTEO-PIN MEMBRANE FIXATION PIN
K990537 · Luitpold Pharmaceuticals, Inc. · Nov 1999
K000149 · NOVABONE-BIOGLASS BONE GRAFT PARTICULATE
Download PDF FDA Summary Usbiomaterials Corp.