Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen
FDA 510(k) K033815 · Geistlich-Pharma
510(k) numberK033815
Submission
- Device name
- Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen
- Applicant
- Geistlich-Pharma
Washington, DC, US - Received
- December 9, 2003
- Decision date
- January 15, 2004
- 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
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|---|---|---|---|
| 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 |
| K240661 | Geistlich Bio-Oss®NPM · Traditional | Geistlich Pharma AG | 07/12/2024SE |
| 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 |
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|---|---|---|
| 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 Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen cleared by the FDA?
Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen (K033815) received a 510(k) decision of Substantially Equivalent on January 15, 2004, 37 days after the submission was received.
What is the product code of K033815?
The FDA product code is NPM – Bone Grafting Material, Animal Source, a Class II (moderate risk) device regulated under 21 CFR 872.3930.