Permamesh-D Hydroxylapatite Matrix
FDA 510(k) K960361 · Ceramed Corp.
510(k) numberK960361
Submission
- Device name
- Permamesh-D Hydroxylapatite Matrix
- Applicant
- Ceramed Corp.
Lakewood, CO, US - Received
- January 25, 1996
- Decision date
- April 15, 1996
- 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 |
|---|---|---|
| K962838 | Permaridge SyringeLYC · Traditional | 08/20/1996SE |
| K962786 | Osteograf Stainless Steel SyringLYC · Traditional | 08/01/1996SE |
| K960348 | OSTEOGRAF/N-300 HydroxylapatiteLYC · Traditional | 04/22/1996SE |
| K960368 | OSTEOGRAFT/N-700 HydroxylaptiteLYC · Traditional | 04/18/1996SE |
| K960353 | OSTEOGRAF/LD-300 HydroxylapatiteLYC · Traditional | 04/18/1996SE |
| K960362 | Permamesh Hydroxylapatite MatrixLZK · Traditional | 03/20/1996SE |
| K960354 | Permamesh-D Hydroxylapatite MatrixLZK · Traditional | 03/20/1996SE |
| K960349 | Permaridge Hydroxylapatite MatrixFWP · Traditional | 03/13/1996SE |
| K954631 | Osteograf/N-Blocck HydroxylapatiteLYC · Traditional | 01/02/1996SE |
| K942946 | OSTEOGRAF/D-100 HydroxylapatiteLYC · Traditional | 10/05/1994SE |
Questions and answers
When was Permamesh-D Hydroxylapatite Matrix cleared by the FDA?
Permamesh-D Hydroxylapatite Matrix (K960361) received a 510(k) decision of Substantially Equivalent on April 15, 1996, 81 days after the submission was received.
What is the product code of K960361?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.