B1018 Porous Ha Bii-Pore
FDA 510(k) K924288 · Bio-Interfaces, Inc.
510(k) numberK924288
Submission
- Device name
- B1018 Porous Ha Bii-Pore
- Applicant
- Bio-Interfaces, Inc.
San Diego, CA, US - Received
- August 25, 1992
- Decision date
- April 14, 1993
- 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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| K201546 | OsOpia Synthetic Bone Void FillerLYC · Traditional | Revisios BV | 10/02/2020SE |
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More from Institut Straumann AG
| 510(k) | Device | Decision |
|---|---|---|
| K960164 | Bio-Interfaces, Inc., Bioresorbable Calcium Phosphate Particles - Bii-Graft 6140LYC · Traditional | 04/10/1996SE |
| K954763 | Bio-Interfaces, Inc,. Bii-PlastLYC · Traditional | 01/04/1996SE |
| K950598 | Bioresorbable Calcium Phosphate Particles - Bll-GraftLYC · Traditional | 08/23/1995SE |
| K950567 | Bio-Apatite 6140 Ha ParticlesLYC · Traditional | 05/09/1995SE |
| K950511 | Bll-Fil 6140 ParticlesLYC · Traditional | 04/27/1995SE |
| K934049 | Bii-Pore(Tm) Canal Wall ProsthesisLYC · Traditional | 07/19/1994SE |
| K933688 | Bii-PoreLYC · Traditional | 07/19/1994SE |
| K941431 | Bone Graft Delivery SyringesEID · Traditional | 07/12/1994SE |
| K934430 | Bon Apatite Ha ParticlesLYC · Traditional | 05/18/1994SE |
| K934947 | Bii-PlastLYC · Traditional | 01/26/1994SE |
Questions and answers
When was B1018 Porous Ha Bii-Pore cleared by the FDA?
B1018 Porous Ha Bii-Pore (K924288) received a 510(k) decision of Substantially Equivalent on April 14, 1993, 232 days after the submission was received.
What is the product code of K924288?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.