Geistlich Bio-Oss®
FDA 510(k) K240661 · Geistlich Pharma AG
510(k) numberK240661
Submission
- Device name
- Geistlich Bio-Oss®
- Applicant
- Geistlich Pharma AG
Wolhusen, CH - Received
- March 8, 2024
- Decision date
- July 12, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K253723 | BossNPM · Traditional | Medpark Co., Ltd. | 06/16/2026SE |
| K251786 | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®NPM · Special | Geistlich Pharma AG | 07/11/2025SE |
| K251613 | SwissGraft XNPM · Special | Geistlich Pharma AG | 06/26/2025SE |
| K242510 | Geistlich Bio-Flow®NPM · Traditional | Geistlich Pharma AG | 03/07/2025SE |
| K240133 | Xenograft Bovine Bone ParticulateNPM · Traditional | Collagen Solutions, LLC | 08/16/2024SE |
| K230305 | THE Graft CollagenNPM · Traditional | Purgo Biologics, Inc. | 07/24/2024SE |
| K231672 | S1NPM · Traditional | Medpark Co., Ltd. | 10/13/2023SE |
| K221808 | InterOss CollagenNPM · Traditional | Sigmagraft, Inc. | 03/18/2023SE |
| K211551 | Wishbone HANPM · Traditional | Wishbone SA | 08/20/2021SE |
| K202183 | Porcine Mineral Collagen CompositeNPM · Traditional | Collagen Matrix, Inc. | 04/02/2021SE |
More from Collagen Matrix, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260364 | Device 300419 StripMQV · Traditional | 06/02/2026SE |
| K260532 | Derma-GideKGN · Special | 03/19/2026SE |
| K251323 | Device 104 ParticulateKGN · Traditional | 01/22/2026SE |
| K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®NPL · Traditional | 11/25/2025SE |
| K251062 | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich…NPL · Traditional | 08/14/2025SE |
| K251556 | Device 300423 GranulesMQV · Traditional | 07/17/2025SE |
| K251786 | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®NPM · Special | 07/11/2025SE |
| K251613 | SwissGraft XNPM · Special | 06/26/2025SE |
| K250833 | SwissMembrane X; SwissMembrane X SocketNPL · Special | 04/15/2025SE |
| K242510 | Geistlich Bio-Flow®NPM · Traditional | 03/07/2025SE |
Questions and answers
When was Geistlich Bio-Oss® cleared by the FDA?
Geistlich Bio-Oss® (K240661) received a 510(k) decision of Substantially Equivalent on July 12, 2024, 126 days after the submission was received.
What is the product code of K240661?
The FDA product code is NPM – Bone Grafting Material, Animal Source, a Class II (moderate risk) device regulated under 21 CFR 872.3930.