Osbone Dental
FDA 510(k) K102872 · Curasan AG
510(k) numberK102872
Submission
- Device name
- Osbone Dental
- Applicant
- Curasan AG
North Attleboro, MA, US - Received
- September 30, 2010
- Decision date
- January 12, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYC – Bone Grafting Material, Synthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3930
- Specialty
- Dental
- Implant
- Yes
A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.
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| K244006 | FG Bone Graft MLYC · Traditional | Full Golden Biotech Co., Ltd. | 09/17/2025SE |
| K243745 | FG Bone Graft BLYC · Traditional | Full Golden Biotech Corporation | 08/29/2025SE |
| K241186 | Synthetic Bone Graft ParticulateLYC · Traditional | Shenzhen Dazhou Medical Technology Co., Ltd. | 02/21/2025SE |
| K213260 | CMFlexTMLYC · Traditional | Dimension Inx Corp. | 12/30/2022SE |
| K202675 | InRoad® Dental Synthetic Bone GraftLYC · Traditional | Osteogene Tech Corp | 03/04/2022SE |
| K201546 | OsOpia Synthetic Bone Void FillerLYC · Traditional | Revisios BV | 10/02/2020SE |
| K201051 | Straumann BoneCeramicLYC · Traditional | Institut Straumann AG | 09/24/2020SE |
More from Institut Straumann AG
| 510(k) | Device | Decision |
|---|---|---|
| K181721 | Ceracell Ortho FoamMQV · Traditional | 09/17/2018SE |
| K160566 | Cerasorb Ortho FoamMQV · Traditional | 12/02/2016SE |
| K111105 | Curasan Osseolive DentalLYC · Abbreviated | 12/20/2012SE |
| K103709 | Ceracell DentalLYC · Abbreviated | 03/10/2011SE |
| K100841 | BoneoptimizerMQV · Special | 08/19/2010SE |
| K063106 | Revois Implant SystemNHA · Abbreviated | 06/11/2007SE |
| K040216 | Cerasorb M OrthoMQV · Special | 03/26/2004SE |
| K031651 | Modification to Cerasorb OrthoMQV · Special | 08/13/2003SE |
| K014156 | Cerasorb OrthoMQV · Traditional | 03/18/2002SE |
Questions and answers
When was Osbone Dental cleared by the FDA?
Osbone Dental (K102872) received a 510(k) decision of Substantially Equivalent on January 12, 2011, 104 days after the submission was received.
What is the product code of K102872?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.