Cleared Traditional

K994137 - ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE

K994137 is an FDA 510(k) clearance for ATRISORB-D FREEFLOW BIOABSORBABLE GUIDE..., manufactured by Atrix Laboratories, Inc.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K994137 · Atrix Laboratories, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
281d
Days
Class 2
Risk

K994137 is an FDA 510(k) clearance for the ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WI.... Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Atrix Laboratories, Inc. (Fort Collins, US). The FDA issued a Cleared decision on September 13, 2000 after a review of 281 days - an extended review 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: 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 Atrix Laboratories, Inc. devices

FDA 510(k) Submission Details - K994137

510(k) Number K994137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1999
Decision Date September 13, 2000
Days to Decision 281 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
154d slower than avg
Panel avg: 127d · This submission: 281d
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 129
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K994137.
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
K010320 · Depuyacromed · Mar 2001
3I CALCIUM SODIUM PHOSPHATE BONE CEMENT
K003493 · Biomet, Inc. · Feb 2001
SYMPHONY GRAFT DELIVERY SYSTEM
K003286 · Depuyacromed · Jan 2001
BIO-BLOCKS
K970569 · Geistlich-Pharma · Aug 2000
FORTOSS-CEMA
K993238 · Biocomposites, Ltd. · Jan 2000
OSTEO-PIN MEMBRANE FIXATION PIN
K990537 · Luitpold Pharmaceuticals, Inc. · Nov 1999