Cleared Traditional

OSTEOGEN (K843398) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K843398 · Impladent · Dental device
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Dec 1984
Decision
120d
Days
Class 2
Risk

K843398 is an FDA 510(k) clearance for the OSTEOGEN. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Impladent (Jackson Heights, US). The FDA issued a Cleared decision on December 27, 1984 after a review of 120 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 Impladent devices

Submission Details

510(k) Number K843398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1984
Decision Date December 27, 1984
Days to Decision 120 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 127d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 25
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K843398.
RESOLUT REGENERATIVE MATERIAL
K970884 · W.L. Gore & Associates, Inc. · May 1997
RESOLUT REGENERATIVE MATERIAL
K962624 · W.L. Gore & Associates, Inc. · Oct 1996
RESOLUT REGENERATIVE MATERIAL
K932866 · W.L. Gore & Associates, Inc. · Mar 1995
HYDROXYAPATITE
K842718 · Depuy, Inc. · Nov 1984
SYNTHOGRAFT LG-AUGMENTATION & BONE FILL
K821752 · Depuy, Inc. · Aug 1982