NPL

Barrier, Animal Source, Intraoral

Product code
NPL
Device name
Barrier, Animal Source, Intraoral
Device class
Class 2
21 CFR
21 CFR 872.3930
Medical specialty
Dental
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
9
Summaries archived here
9 (direct download)
510(k) clearances (all years, FDA)
57 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (9)

Last three years. Most recent: 2025-12-12.

NumberDecision dateApplicantDevice nameSummary
K2428172025-12-12Botiss Biomaterials GmbHJason membranePDF
K2505122025-12-05Neo Modulus (Suzhou) Medical Sci-Tech …Augmented Gingival MatrixPDF
K2522532025-11-25Geistlich Pharma AGGeistlich Mucograft® /Geistlich Mucograft® Seal; Ge…PDF
K2510622025-08-14Geistlich Pharma AGGeistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geist…PDF
K2508332025-04-15Geistlich Pharma AGSwissMembrane X; SwissMembrane X SocketPDF
K2332032024-05-01Collagen Matrix, Inc.Soft Tissue Augmentation Resorbable MatrixPDF
K2315132024-02-16Beijing Biosis Healing Biolog Ical Tec…Oral MatrixPDF
K2313052024-01-23Aroa Biosurgery , Ltd.Endoform Dental MembranePDF
K2300912023-10-06Purgo Biologics, Inc.THE CoverPDF

9 summaries are archived here for direct download.

Official FDA classification page: NPL
Classification and pathway per current FDA publications. Data from openFDA (CC0).