Cleared Traditional

BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION (K001598) - FDA 510(k) Clearance

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

K001598 · Col-Bar , Ltd. · Dental device
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Aug 2000
Decision
90d
Days
Class 2
Risk

K001598 is an FDA 510(k) clearance for the BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Col-Bar , Ltd. (Washington, US). The FDA issued a Cleared decision on August 22, 2000 after a review of 90 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 Col-Bar , Ltd. devices

Submission Details

510(k) Number K001598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2000
Decision Date August 22, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
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 20
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K001598.
MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER
K010701 · Medtronic Sofamor Danek USA, Inc. · Jun 2001
MIMIX BONE REPLACEMENT SYSTEM
K003494 · Biomet, Inc. · Apr 2001
3I CALCIUM SODIUM PHOSPHATE BONE CEMENT
K003493 · Biomet, Inc. · Feb 2001
ENDOBON
K980679 · Biomet, Inc. · Apr 1998
HYDROXYAPATITE
K842718 · Depuy, Inc. · Nov 1984
SYNTHOGRAFT LG-AUGMENTATION & BONE FILL
K821752 · Depuy, Inc. · Aug 1982