Cleared Traditional

K992416 - PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE

K992416 is an FDA 510(k) clearance for PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE, manufactured by Usbiomaterials Corp.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K992416 · Usbiomaterials Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
87d
Days
Class 2
Risk

K992416 is an FDA 510(k) clearance for the PERIOGLAS- 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 October 15, 1999 after a review of 87 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Usbiomaterials Corp. devices

FDA 510(k) Submission Details - K992416

510(k) Number K992416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1999
Decision Date October 15, 1999
Days to Decision 87 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
40d faster than avg
Panel avg: 127d · This submission: 87d
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 144
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K992416.
UNIGRAFT
K993784 · Unicare Biomedical · Jan 2000
FORTOSS-CEMA
K993238 · Biocomposites, Ltd. · Jan 2000
OSTEO-PIN MEMBRANE FIXATION PIN
K990537 · Luitpold Pharmaceuticals, Inc. · Nov 1999
BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE
K992216 · Integra Lifesciences Corp. · Jul 1999
NORIAN PERIODONTAL/DENTAL CEMENT (PDC)
K983104 · Norian Corp. · Feb 1999
UNIGRAFE
K982699 · Unicare Biomedical · Oct 1998