Cleared Abbreviated

GUIDOR BIORESORBABLE MATRIX BARRIER

K132325 · Sunstar Americas, Inc. · Dental

Oct 2013

Decision

95d

Days

Class 2

Risk

About This 510(k) Submission

K132325 is an FDA 510(k) clearance for the GUIDOR BIORESORBABLE MATRIX BARRIER, a Barrier, Synthetic, Intraoral (Class II — Special Controls, product code NPK), submitted by Sunstar Americas, Inc. (New York, US). The FDA issued a Cleared decision on October 29, 2013, 95 days after receiving the submission on July 26, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K132325 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 26, 2013
Decision Date	October 29, 2013
Days to Decision	95 days
Submission Type	Abbreviated
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NPK — Barrier, Synthetic, Intraoral
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3930
Definition	A Synthetic Dental Barrier Is A Synthetic Material Device, Such As Ptfe, Intended To Aid In Guided Tissue And/or Bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials.