S1

FDA 510(k) K231672 · Medpark Co., Ltd.

Substantially Equivalent

510(k) numberK231672

Submission

Device name
S1
Applicant
Medpark Co., Ltd.
Buk-Gu, KR
Received
June 8, 2023
Decision date
October 13, 2023
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.

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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
K230305THE Graft CollagenNPM · Traditional Purgo Biologics, Inc.07/24/2024SE
K240661Geistlich Bio-Oss®NPM · Traditional Geistlich Pharma AG07/12/2024SE
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
K253723BossNPM · Traditional 06/16/2026SE

Questions and answers

When was S1 cleared by the FDA?

S1 (K231672) received a 510(k) decision of Substantially Equivalent on October 13, 2023, 127 days after the submission was received.

What is the product code of K231672?

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