Osteogen (Ha Resorb)
FDA 510(k) K923310 · Impladent
510(k) numberK923310
Submission
- Device name
- Osteogen (Ha Resorb)
- Applicant
- Impladent
Hollis, NY, US - Received
- July 7, 1992
- Decision date
- May 31, 1995
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K141764 | Tristar Bone Graft Fixation SystemJEY · Traditional | 12/18/2014SE |
| K090794 | OsteotapeNPM · Traditional | 12/10/2009SE |
| K033098 | Osteogen SBRGLYC · Traditional | 04/27/2004SE |
| K982925 | Laminoss Dental ImplantDZE · Traditional | 05/18/1999SE |
| K933705 | Laminoss Dental ImplantDZE · Traditional | 06/24/1996SE |
| K881662 | Expanded Claimes to Osteogen(R)DZE · Traditional | 09/01/1988SN |
| K843398 | OsteogenLYC · Traditional | 12/27/1984SE |
| K812321 | Hydroxi-Flex ImplantDZE · Traditional | 10/29/1981SE |
| K792663 | Flexi-Cup ImplantDZE · Traditional | 01/09/1980SE |
Questions and answers
When was Osteogen (Ha Resorb) cleared by the FDA?
Osteogen (Ha Resorb) (K923310) received a 510(k) decision of Substantially Equivalent on May 31, 1995, 1,058 days after the submission was received.
What is the product code of K923310?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.