510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K001598Substantially Equivalent

Biobar, Implantable Biodegradable Collagen Membrane for Guided Bone Regeneration

Col-Bar, Ltd., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001598 is the FDA 510(k) clearance record for BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION, a class II device, cleared for Col-Bar , Ltd. on under FDA product code LYC (Bone Grafting Material, Synthetic). FDA's definition for product code LYC reads: "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". FDA records list one 510(k) clearance for Col-Bar , Ltd. As of , FDA records show no recalls naming K001598.

Clearance record

Decision date
Received
(90 days to decision)
Product code
LYC Bone Grafting Material, Synthetic
Regulation
21 CFR 872.3930
Device class
Class II
Review panel
Dental
Applicant
Col-Bar , Ltd. 555 13th St., NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code LYC

Trailing 12 months
3 clearances under product code LYC in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LYC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260