NPM

Bone Grafting Material, Animal Source

Product code
NPM
Device name
Bone Grafting Material, Animal Source
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)
8
Summaries archived here
6 (direct download)
510(k) clearances (all years, FDA)
40 (all years; only the last 3 years are listed here)

FDA classification definition

A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.

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

510(k) clearances, last 3 years (8)

Last three years. Most recent: 2026-06-16.

NumberDecision dateApplicantDevice nameSummary
K2537232026-06-16Medpark Co., Ltd.BOSSPDF
K2517862025-07-11Geistlich Pharma AGGeistlich Bio-Oss®; Geistlich Bio-Oss Pen®FDA
K2516132025-06-26Geistlich Pharma AGSwissGraft XPDF
K2425102025-03-07Geistlich Pharma AGGeistlich Bio-Flow®FDA
K2401332024-08-16Collagen Solutions, LLCXenograft Bovine Bone ParticulatePDF
K2303052024-07-24Purgo Biologics, Inc.THE Graft CollagenPDF
K2406612024-07-12Geistlich Pharma AGGeistlich Bio-Oss®PDF
K2316722023-10-13Medpark Co., Ltd.S1PDF

6 summaries are archived here for direct download.

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