Bio-Oss
FDA 510(k) K952617 · Geistlich-Pharma
510(k) numberK952617
Submission
- Device name
- Bio-Oss
- Applicant
- Geistlich-Pharma
Washington, DC, US - Received
- June 6, 1995
- Decision date
- August 7, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| 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 cleared by the FDA?
Bio-Oss (K952617) received a 510(k) decision of Substantially Equivalent on August 7, 1995, 62 days after the submission was received.
What is the product code of K952617?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.