Periophil B-Tcp
FDA 510(k) K093871 · Cytophil, Inc.
510(k) numberK093871
Submission
- Device name
- Periophil B-Tcp
- Applicant
- Cytophil, Inc.
East Troy, WI, US - Received
- December 17, 2009
- Decision date
- April 22, 2010
- 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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More from Institut Straumann AG
| 510(k) | Device | Decision |
|---|---|---|
| K150400 | Renu GelMIX · Special | 04/06/2015SE |
| K121795 | Calcium Hydroxylapatite Vocal Fold ImplantMIX · Traditional | 02/22/2013SE |
| K102937 | Osteophil Beta-TcpMQV · Traditional | 12/27/2010SE |
| K092788 | Periophil BiphasicLYC · Traditional | 12/18/2009SE |
| K081816 | Vocalis and Vocalis SMMIX · Traditional | 01/05/2009SE |
| K081815 | Vocalis GelMIX · Traditional | 01/05/2009SE |
| K072219 | Cytophil Tissue MarkerNEU · Traditional | 01/18/2008SE |
Questions and answers
When was Periophil B-Tcp cleared by the FDA?
Periophil B-Tcp (K093871) received a 510(k) decision of Substantially Equivalent on April 22, 2010, 126 days after the submission was received.
What is the product code of K093871?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.