A-Oss
FDA 510(k) K151542 · Hiossen, Inc.
510(k) numberK151542
Submission
- Device name
- A-Oss
- Applicant
- Hiossen, Inc.
Fariless Hills, PA, US - Received
- June 8, 2015
- Decision date
- August 3, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
More from Wishbone SA
| 510(k) | Device | Decision |
|---|---|---|
| K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsNHA · Traditional | 05/14/2026SE |
| K251427 | Ek Multi Angled 30 AbutmentNHA · Traditional | 01/29/2026SE |
| K241003 | HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)NHA · Abbreviated | 01/08/2025SE |
| K240232 | EK D3.3 and Ultra Wide ImplantsDZE · Traditional | 09/13/2024SE |
| K233389 | EK Digital AbutmentsNHA · Traditional | 05/29/2024SE |
| K222636 | ET Abutment SystemNHA · Traditional | 04/28/2023SE |
| K203360 | EK Implants and Abutments SystemDZE · Traditional | 01/07/2022SE |
| K191751 | EM ProvisionalDZE · Abbreviated | 12/16/2019SE |
| K191201 | EM SA Implant SystemDZE · Traditional | 11/15/2019SE |
| K183242 | ET IV SA Dental ImplantsDZE · Special | 05/21/2019SE |
Questions and answers
When was A-Oss cleared by the FDA?
A-Oss (K151542) received a 510(k) decision of Substantially Equivalent on August 3, 2016, 422 days after the submission was received.
What is the product code of K151542?
The FDA product code is NPM – Bone Grafting Material, Animal Source, a Class II (moderate risk) device regulated under 21 CFR 872.3930.