Osteogen SBRG
FDA 510(k) K033098 · Impladent , Ltd.
510(k) numberK033098
Submission
- Device name
- Osteogen SBRG
- Applicant
- Impladent , Ltd.
Hollis, NY, US - Received
- September 29, 2003
- Decision date
- April 27, 2004
- 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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| K241186 | Synthetic Bone Graft ParticulateLYC · Traditional | Shenzhen Dazhou Medical Technology Co., Ltd. | 02/21/2025SE |
| K213260 | CMFlexTMLYC · Traditional | Dimension Inx Corp. | 12/30/2022SE |
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| 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 |
| K982925 | Laminoss Dental ImplantDZE · Traditional | 05/18/1999SE |
| K933705 | Laminoss Dental ImplantDZE · Traditional | 06/24/1996SE |
| K923310 | Osteogen (Ha Resorb)LYC · Traditional | 05/31/1995SE |
| 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 SBRG cleared by the FDA?
Osteogen SBRG (K033098) received a 510(k) decision of Substantially Equivalent on April 27, 2004, 211 days after the submission was received.
What is the product code of K033098?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.