Fortagen Oral Membrane

FDA 510(k) K071555 · Organogenesis, Inc.

Substantially Equivalent

510(k) numberK071555

Submission

Device name
Fortagen Oral Membrane
Applicant
Organogenesis, Inc.
Canton, MA, US
Received
June 7, 2007
Decision date
August 30, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NPL – Barrier, Animal Source, Intraoral
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3930
Specialty
Dental
Implant
Yes

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.

Other 510(k)s with product code NPL

510(k)DeviceApplicantDecision
K242817Jason membraneNPL · Traditional Botiss Biomaterials GmbH12/12/2025SE
K250512Augmented Gingival MatrixNPL · Traditional Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.12/05/2025SE
K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®NPL · Traditional Geistlich Pharma AG11/25/2025SE
K251062Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich…NPL · Traditional Geistlich Pharma AG08/14/2025SE
K250833SwissMembrane X; SwissMembrane X SocketNPL · Special Geistlich Pharma AG04/15/2025SE
K233203Soft Tissue Augmentation Resorbable MatrixNPL · Traditional Collagen Matrix, Inc.05/01/2024SE
K231513Oral MatrixNPL · Traditional Beijing Biosis Healing Biolog Ical Technology…02/16/2024SE
K231305Endoform Dental MembraneNPL · Traditional Aroa Biosurgery , Ltd.01/23/2024SE
K230091THE CoverNPL · Traditional Purgo Biologics, Inc.10/06/2023SE
K223912InterCollagen® GuideNPL · Traditional Sigmagraft, Inc.08/17/2023SE

More from Sigmagraft, Inc.

510(k)DeviceDecision
K212579FortiShield (Biosynthetic Wound Matrix)KGN · Traditional 05/02/2023SE
K220317PuraPly Micronized Wound Matrix (PuraPly MZ)KGN · Traditional 07/01/2022SE
K051647Fortaderm Antimicrobial Wound DressingFRO · Traditional 11/08/2005SE
K042809CuffpatchFTM · Traditional 11/02/2004SE
K021107Fortaflex Surgical SlingFTM · Traditional 05/15/2002SE
K021105Fortaflex Surgical MeshFTM · Traditional 05/10/2002SE
K020049Fortaflex Surgical MeshFTM · Traditional 03/18/2002SE
K011025Fortaflex Surgical MeshFTM · Traditional 08/24/2001SE
K011026Fortaderm Wound DressingKGN · Traditional 06/13/2001SE
K011027Fortaflex Surgical SlingFTM · Traditional 05/30/2001SE

Questions and answers

When was Fortagen Oral Membrane cleared by the FDA?

Fortagen Oral Membrane (K071555) received a 510(k) decision of Substantially Equivalent on August 30, 2007, 84 days after the submission was received.

What is the product code of K071555?

The FDA product code is NPL – Barrier, Animal Source, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.3930.