Cleared Traditional

K960353 - OSTEOGRAF/LD-300 HYDROXYLAPATITE

K960353 is an FDA 510(k) clearance for OSTEOGRAF/LD-300 HYDROXYLAPATITE, manufactured by Ceramed Corp.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K960353 · Ceramed Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
84d
Days
Class 2
Risk

K960353 is an FDA 510(k) clearance for the OSTEOGRAF/LD-300 HYDROXYLAPATITE. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Ceramed Corp. (Lakewood, US). The FDA issued a Cleared decision on April 18, 1996 after a review of 84 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 Ceramed Corp. devices

FDA 510(k) Submission Details - K960353

510(k) Number K960353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1996
Decision Date April 18, 1996
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
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 122
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K960353.
PERMARIDGE SYRINGE
K962838 · Ceramed Corp. · Aug 1996
OSTEOGRAF STAINLESS STEEL SYRING
K962786 · Ceramed Corp. · Aug 1996
OSTEOGRAF/N-300 HYDROXYLAPATITE
K960348 · Ceramed Corp. · Apr 1996
OSTEOGRAFT/N-700 HYDROXYLAPTITE
K960368 · Ceramed Corp. · Apr 1996
PERMAMESH-D HYDROXYLAPATITE MATRIX
K960361 · Ceramed Corp. · Apr 1996
BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140
K960164 · Bio-Interfaces, Inc. · Apr 1996