Straumann cerabone
FDA 510(k) K173594 · Institut Straumann AG
510(k) numberK173594
Submission
- Device name
- Straumann cerabone
- Applicant
- Institut Straumann AG
Basel, CH - Received
- November 21, 2017
- Decision date
- October 19, 2018
- 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 |
| 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 |
|---|---|---|
| K260726 | Straumann® ProClean Cassette (041.800 ; 041.801)KCT · Traditional | 06/03/2026SE |
| K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueNHA · Traditional | 05/07/2026SE |
| K252168 | Straumann® BLC Implants - Indication WideningDZE · Traditional | 03/10/2026SE |
| K253315 | Straumann Variobase Abutments XC for Bridge/BarNHA · Traditional | 01/22/2026SE |
| K250294 | Straumann® RidgeFit ImplantsDZE · Traditional | 08/12/2025SE |
| K243278 | Custom AbutmentsNHA · Traditional | 02/21/2025SE |
| K243478 | Straumann InLab Validated WorkflowNHA · Traditional | 02/19/2025SE |
| K233252 | Straumann CARES Visual and Nova Dental CADPNP · Traditional | 12/26/2024SE |
| K241391 | Straumann® PURE Ceramic ImplantsDZE · Traditional | 12/10/2024SE |
| K234049 | Straumann® BLC and TLC Implants - Line extensionDZE · Traditional | 03/20/2024SE |
Questions and answers
When was Straumann cerabone cleared by the FDA?
Straumann cerabone (K173594) received a 510(k) decision of Substantially Equivalent on October 19, 2018, 332 days after the submission was received.
What is the product code of K173594?
The FDA product code is NPM – Bone Grafting Material, Animal Source, a Class II (moderate risk) device regulated under 21 CFR 872.3930.