Cleared Traditional

Oral Matrix

K231513 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · Dental

Feb 2024

Decision

267d

Days

Class 2

Risk

About This 510(k) Submission

K231513 is an FDA 510(k) clearance for the Oral Matrix, a Barrier, Animal Source, Intraoral (Class II — Special Controls, product code NPL), submitted by Beijing Biosis Healing Biolog Ical Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on February 16, 2024, 267 days after receiving the submission on May 25, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K231513 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 25, 2023
Decision Date	February 16, 2024
Days to Decision	267 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.