Cleared Traditional

Kerecis Gingiva Graft

K192612 · Kerecis Limited · Dental

Nov 2020

Decision

420d

Days

Class 2

Risk

About This 510(k) Submission

K192612 is an FDA 510(k) clearance for the Kerecis Gingiva Graft, a Barrier, Animal Source, Intraoral (Class II — Special Controls, product code NPL), submitted by Kerecis Limited (Isafjordur, IS). The FDA issued a Cleared decision on November 13, 2020, 420 days after receiving the submission on September 20, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K192612 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2019
Decision Date	November 13, 2020
Days to Decision	420 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.