Cleared Traditional

GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS

K102307 · Genoss Co., Ltd. · Dental

May 2011

Decision

261d

Days

Class 2

Risk

About This 510(k) Submission

K102307 is an FDA 510(k) clearance for the GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS, a Barrier, Animal Source, Intraoral (Class II — Special Controls, product code NPL), submitted by Genoss Co., Ltd. (Cypress, US). The FDA issued a Cleared decision on May 4, 2011, 261 days after receiving the submission on August 16, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K102307 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 16, 2010
Decision Date	May 04, 2011
Days to Decision	261 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NPL — Barrier, Animal Source, Intraoral
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3930
Definition	An Animal Source Dental Barrier Is An Animal-derived Material Device, Such As Collagen, Intended To Aid In Guided Tissue/bone Regeneration Procedures And To Act As A Stable Barrier For The Containment Of Bone Graft Materials When Placed Around Implants.