Cleared Traditional

Striate+?

K201241 · Orthocell, Ltd. · Dental

Jan 2021

Decision

248d

Days

Class 2

Risk

About This 510(k) Submission

K201241 is an FDA 510(k) clearance for the Striate+?, a Barrier, Animal Source, Intraoral (Class II — Special Controls, product code NPL), submitted by Orthocell, Ltd. (Perth, AU). The FDA issued a Cleared decision on January 11, 2021, 248 days after receiving the submission on May 8, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K201241 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 2020
Decision Date	January 11, 2021
Days to Decision	248 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.