Novabone-Bioglass Bone Graft Particulate
FDA 510(k) K000149 · Usbiomaterials Corp.
510(k) numberK000149
Submission
- Device name
- Novabone-Bioglass Bone Graft Particulate
- Applicant
- Usbiomaterials Corp.
Alachua, FL, US - Received
- January 19, 2000
- Decision date
- February 7, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
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| 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 |
|---|---|---|
| K024343 | Butler Gum Prophy Paste with NovaminEJR · Traditional | 07/11/2003SE |
| K992416 | Perioglas- Bioglass Bone Graft ParticulateLYC · Traditional | 10/15/1999SE |
| K962494 | Perioglas - Bioglass Bone Graft ParticulateLYC · Traditional | 09/20/1996SE |
| K930115 | PerioglassLYC · Traditional | 11/04/1993SE |
Questions and answers
When was Novabone-Bioglass Bone Graft Particulate cleared by the FDA?
Novabone-Bioglass Bone Graft Particulate (K000149) received a 510(k) decision of Substantially Equivalent on February 7, 2000, 19 days after the submission was received.
What is the product code of K000149?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.