Cleared Traditional

Endoform Dental Membrane

K231305 · Aroa Biosurgery , Ltd. · Dental

Jan 2024

Decision

263d

Days

Class 2

Risk

About This 510(k) Submission

K231305 is an FDA 510(k) clearance for the Endoform Dental Membrane, a Barrier, Animal Source, Intraoral (Class II — Special Controls, product code NPL), submitted by Aroa Biosurgery , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on January 23, 2024, 263 days after receiving the submission on May 5, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K231305 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 05, 2023
Decision Date	January 23, 2024
Days to Decision	263 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.