Bone Plus BCP Eagle Eye
FDA 510(k) K122240 · Megagen Implant Co., Ltd.
510(k) numberK122240
Submission
- Device name
- Bone Plus BCP Eagle Eye
- Applicant
- Megagen Implant Co., Ltd.
Brea, CA, US - Received
- July 27, 2012
- Decision date
- August 21, 2012
- 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.
Other 510(k)s with product code LYC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253317 | Cytrans ElashieldLYC · Traditional | GC America, Inc. | 07/06/2026SE |
| 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 |
|---|---|---|
| K251232 | MegaGen Zygoma Dental Implant SystemDZE · Traditional | 06/18/2026SE |
| K242030 | MegaGen Dental Implant AbutmentNHA · Traditional | 01/13/2025SE |
| K241972 | Bluediamond ImplantDZE · Traditional | 12/27/2024SE |
| K234142 | TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentNHA · Traditional | 09/18/2024SE |
| K240754 | N2EIA · Special | 03/21/2024SE |
| K233450 | MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary…NHA · Traditional | 01/22/2024SE |
| K231967 | ARi ExCon Implant SystemDZE · Traditional | 12/07/2023SE |
| K223909 | R2GATE Lite TMLLZ · Traditional | 10/20/2023SE |
| K230618 | MegaGen Dental Implant Systems Portfolio - MR ConditionalDZE · Traditional | 10/11/2023SE |
| K223339 | Bone Chamber ImplantDZE · Traditional | 07/18/2023SE |
Questions and answers
When was Bone Plus BCP Eagle Eye cleared by the FDA?
Bone Plus BCP Eagle Eye (K122240) received a 510(k) decision of Substantially Equivalent on August 21, 2012, 25 days after the submission was received.
What is the product code of K122240?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.