NPL · Class II · 21 CFR 872.3930

FDA Product Code NPL: Barrier, Animal Source, Intraoral

FDA product code NPL covers animal-derived intraoral barriers used in dental procedures.

These natural membrane materials — typically derived from bovine or porcine collagen — are used as resorbable barriers in guided bone regeneration and guided tissue regeneration procedures. They separate epithelial tissue from bone defects, allowing selective repopulation by osteogenic cells.

NPL devices are Class II medical devices, regulated under 21 CFR 872.3930 and reviewed by the FDA Dental panel.

Leading manufacturers include Collagen Matrix, Inc., Geistlich Pharma AG and Ed. Geistlich Soehne AG Fuer Chemische Industrie.

58
Total
58
Cleared
223d
Avg days
2001
Since
Stable submission activity - 6 submissions in the last 2 years
Review times improving: avg 188d recently vs 227d historically

FDA 510(k) Cleared Barrier, Animal Source, Intraoral Devices (Product Code NPL)

58 devices
1–24 of 58
Cleared Oct 29, 2026
OSSIX Plus
K262415
Datum Dental, Ltd.
Dental · 106d
Cleared Dec 12, 2025
Jason membrane
K242817
Botiss Biomaterials GmbH
Dental · 450d
Cleared Dec 05, 2025
Augmented Gingival Matrix
K250512
Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.
Dental · 287d
Cleared Nov 25, 2025
Geistlich Mucograft® /Geistlich Mucograft® Seal
K252253
Geistlich Pharma AG
Dental · 127d
Cleared Aug 14, 2025
Geistlich Bio-Gide
K251062
Geistlich Pharma AG
Dental · 132d
Cleared Apr 15, 2025
SwissMembrane X
K250833
Geistlich Pharma AG
Dental · 27d
Cleared May 01, 2024
Soft Tissue Augmentation Resorbable Matrix
K233203
Collagen Matrix, Inc.
Dental · 216d
Cleared Feb 16, 2024
Oral Matrix
K231513
Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
Dental · 267d
Cleared Jan 23, 2024
Endoform Dental Membrane
K231305
Aroa Biosurgery , Ltd.
Dental · 263d
Cleared Oct 06, 2023
THE Cover
K230091
Purgo Biologics, Inc.
Dental · 267d
Cleared Aug 17, 2023
InterCollagen® Guide
K223912
Sigmagraft, Inc.
Dental · 231d
Cleared Sep 30, 2022
Kerecis Oral
K213904
Kerecis
Dental · 290d
Cleared Jul 18, 2022
OSSIX Breeze
K212509
Datum Dental, Ltd.
Dental · 343d
Cleared Apr 05, 2022
Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack
K212463
Geistlich Pharma AG
Dental · 242d
Cleared Mar 03, 2021
Geistlich Mucograft®, Geistlich Mucograft® Seal
K210280
Geistlich Pharma AG
Dental · 30d
Cleared Jan 11, 2021
Striate+™
K201241
Orthocell, Ltd.
Dental · 248d
Cleared Nov 13, 2020
Kerecis Gingiva Graft
K192612
Kerecis Limited
Dental · 420d
Cleared Oct 02, 2020
OssGuide
K200623
Sk Bioland Co., Ltd.
Dental · 207d
Cleared Aug 29, 2019
Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal
K192042
Geistlich Pharma AG
Dental · 29d
Cleared Jul 09, 2018
Straumann Jason Membrane
K173562
Institut Straumann AG
Dental · 234d
Cleared Nov 09, 2017
Geistlich Fibro-Gide
K171050
Geistlich Pharma AG
Dental · 216d
Cleared Oct 30, 2017
Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed
K171643
Geistlich Pharma AG
Dental · 150d
Cleared Jan 13, 2017
DynaMatrix/Dynamatrix Plus
K161762
Cook Biotech Incorporated
Dental · 200d
Cleared Aug 04, 2016
OSSIX VOLUMAX
K153549
Datum Dental, Ltd.
Dental · 237d

About Product Code NPL - Regulatory Context

510(k) Submission Activity

58 total 510(k) submissions under product code NPL since 2001, with 58 receiving FDA clearance (average review time: 223 days).

Submission volume has remained relatively stable over the observed period, with 6 submissions in the last 24 months.

FDA 510(k) Review Time - NPL Product Code

Recent submissions under NPL have taken an average of 188 days to reach a decision - down from 227 days historically, suggesting improved FDA processing for this classification.

NPL devices are reviewed by the Dental panel. Browse all Dental devices →