Cleared Traditional

TRICOS A RESORBABLE SUBSTITUTE

K081721 · Baxter Healthcare Corp · Dental

Aug 2008

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K081721 is an FDA 510(k) clearance for the TRICOS A RESORBABLE SUBSTITUTE, a Bone Grafting Material, Synthetic (Class II — Special Controls, product code LYC), submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on August 6, 2008, 49 days after receiving the submission on June 18, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K081721 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 18, 2008
Decision Date	August 06, 2008
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	LYC — Bone Grafting Material, Synthetic
Device Class	Class II — 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.