THE Graft Collagen

FDA 510(k) K230305 · Purgo Biologics, Inc.

Substantially Equivalent

510(k) numberK230305

Submission

Device name
THE Graft Collagen
Applicant
Purgo Biologics, Inc.
Seongnam-Si, KR
Received
February 3, 2023
Decision date
July 24, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NPM – Bone Grafting Material, Animal Source
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3930
Specialty
Dental
Implant
Yes

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.

Other 510(k)s with product code NPM

510(k)DeviceApplicantDecision
K253723BossNPM · Traditional Medpark Co., Ltd.06/16/2026SE
K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®NPM · Special Geistlich Pharma AG07/11/2025SE
K251613SwissGraft XNPM · Special Geistlich Pharma AG06/26/2025SE
K242510Geistlich Bio-Flow®NPM · Traditional Geistlich Pharma AG03/07/2025SE
K240133Xenograft Bovine Bone ParticulateNPM · Traditional Collagen Solutions, LLC08/16/2024SE
K240661Geistlich Bio-Oss®NPM · Traditional Geistlich Pharma AG07/12/2024SE
K231672S1NPM · Traditional Medpark Co., Ltd.10/13/2023SE
K221808InterOss CollagenNPM · Traditional Sigmagraft, Inc.03/18/2023SE
K211551Wishbone HANPM · Traditional Wishbone SA08/20/2021SE
K202183Porcine Mineral Collagen CompositeNPM · Traditional Collagen Matrix, Inc.04/02/2021SE

More from Collagen Matrix, Inc.

510(k)DeviceDecision
K230091THE CoverNPL · Traditional 10/06/2023SE
K222549OpenTexNPK · Traditional 05/11/2023SE
K191737The Graft Bone SubstituteNPM · Traditional 02/14/2020SE
K180992BiotexNBY · Abbreviated 07/16/2019SE
K173188The Graft Natural Bone SubstituteNPM · Abbreviated 07/20/2018SE

Questions and answers

When was THE Graft Collagen cleared by the FDA?

THE Graft Collagen (K230305) received a 510(k) decision of Substantially Equivalent on July 24, 2024, 537 days after the submission was received.

What is the product code of K230305?

The FDA product code is NPM – Bone Grafting Material, Animal Source, a Class II (moderate risk) device regulated under 21 CFR 872.3930.