510(k) K210797
- Device
- Bio-MEM Ti Reinforced Membrane
- Applicant
- B&Medi Co., Ltd.
- 510(k) number
- K210797
- Product code
- LYC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-08-18
- Date received
- 2021-03-16
- Regulation
- 872.3930
- Classification name
- Bone Grafting Material, Synthetic
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Taesu Kwon
- Address
- 56-33, Chukhang-Daero 296beon-Gil, Jung-Gu Incheon KR 22339 22339
FDA Registration Numbers#
- 3014448321
- 3005115116
- 1221051
- 9710629
- 1650372
- 2024024
- 2249852
- 1066741
- 2032542
- 9681465
- 8044131
- 3002807310
- 3012101664
- 3027448274
- 1647149
- 1018470
- 3004431266
- 3011276344
- 9613348
- 3017399129
- 3003300673
- 3013820501
- 8010177
- 3006540014
Source Documents#
Other 510(k) Records For Product Code LYC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253883 | Bonalive Maxillofacial | Bonalive , Ltd. | 2026-05-14 |
| K251818 | BONTREE PLUS | Hudens Bio Co., Ltd. | 2026-03-06 |
| K244006 | FG Bone Graft M | Full Golden Biotech Co., Ltd. | 2025-09-17 |
| K243745 | FG Bone Graft B | Full Golden Biotech Corporation | 2025-08-29 |
| K241186 | Synthetic Bone Graft Particulate | Shenzhen Dazhou Medical Technology Co., Ltd. | 2025-02-21 |
| K213260 | CMFlexTM | Dimension Inx Corp. | 2022-12-30 |
| K202675 | InRoad® Dental Synthetic Bone Graft | Osteogene Tech Corp | 2022-03-04 |
| K201546 | OsOpia Synthetic Bone Void Filler | Revisios BV | 2020-10-02 |
| K201051 | Straumann BoneCeramic | Institut Straumann AG | 2020-09-24 |
| K192597 | Cytrans Granules | GC America, Inc. | 2020-08-17 |
| K153676 | OSTEON III | Genoss Co., Ltd. | 2016-09-14 |
| K153230 | ShefaBone SCPC Resorbable Bone Graft | The Implantech Inc./Shefabone | 2016-07-14 |
| K140374 | MASTERGRAFT PUTTY | Medtronic Sofamor Danek USA, Inc. | 2014-06-10 |
| K121177 | BOND APATITE | Augma Biomaterials, Ltd. | 2013-12-05 |
| K131385 | EASY-GRAFT | Degradable Solutions AG | 2013-09-27 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases