Cleared Traditional

K981182 - OSTEOGRAF/N-300

K981182 is an FDA 510(k) clearance for OSTEOGRAF/N-300, manufactured by Ceramed Dental, LLC. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K981182 · Ceramed Dental, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
92d
Days
Class 2
Risk

K981182 is an FDA 510(k) clearance for the OSTEOGRAF/N-300. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Ceramed Dental, LLC (Lakewood, US). The FDA issued a Cleared decision on July 2, 1998 after a review of 92 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 Ceramed Dental, LLC devices

FDA 510(k) Submission Details - K981182

510(k) Number K981182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1998
Decision Date July 02, 1998
Days to Decision 92 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
35d faster than avg
Panel avg: 127d · This submission: 92d
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 150
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K981182.
BIO-OSS COLLAGEN
K974399 · Geistlich-Pharma · Sep 1998
BIO-OSS ANORGANIC BOVINE BONE
K970321 · Geistlich-Pharma · Sep 1998
RESOR-PIN RESORBABLE MEMBRANE PIN
K972817 · Geistlich-Pharma · Jul 1998
OSTEOGRAF/N-700
K981214 · Ceramed Dental, LLC · Jun 1998
ENDOBON
K980679 · Biomet, Inc. · Apr 1998
GORE RESOLUT XT REGENERATIVE MATERIAL
K973594 · W.L. Gore & Associates, Inc. · Dec 1997