Cleared Special

Geistlich Mucograft?, Geistlich Mucograft? Seal

K210280 · Geistlich Pharma AG · Dental

Mar 2021

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K210280 is an FDA 510(k) clearance for the Geistlich Mucograft?, Geistlich Mucograft? Seal, a Barrier, Animal Source, Intraoral (Class II — Special Controls, product code NPL), submitted by Geistlich Pharma AG (Wolhusen, CH). The FDA issued a Cleared decision on March 3, 2021, 30 days after receiving the submission on February 1, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K210280 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2021
Decision Date	March 03, 2021
Days to Decision	30 days
Submission Type	Special
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.