Permamesh Hydroxylapatite Matrix
FDA 510(k) K921468 · Ceramed Corp.
510(k) numberK921468
Submission
- Device name
- Permamesh Hydroxylapatite Matrix
- Applicant
- Ceramed Corp.
Lakewood, CO, US - Received
- March 27, 1992
- Decision date
- August 21, 1992
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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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| K253883 | Bonalive MaxillofacialLYC · Special | Bonalive , Ltd. | 05/14/2026SE |
| K251818 | Bontree PlusLYC · Traditional | Hudens Bio Co., Ltd. | 03/06/2026SE |
| 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 |
|---|---|---|
| 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 |
| K960361 | Permamesh-D Hydroxylapatite MatrixLYC · Traditional | 04/15/1996SE |
| 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 |
Questions and answers
When was Permamesh Hydroxylapatite Matrix cleared by the FDA?
Permamesh Hydroxylapatite Matrix (K921468) received a 510(k) decision of Substantially Equivalent for Some Indications on August 21, 1992, 147 days after the submission was received.
What is the product code of K921468?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.