Orthovita Biogran
FDA 510(k) K941780 · Orthovita Co.
510(k) numberK941780
Submission
- Device name
- Orthovita Biogran
- Applicant
- Orthovita Co.
Princeton, NJ, US - Received
- April 15, 1994
- Decision date
- February 10, 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.
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 |
|---|---|---|
| K163621 | Vitoss Bioactive (BA) InjectableMQV · Traditional | 05/02/2017SE |
| K161447 | HydroSet XTMQV · Traditional | 10/06/2016SE |
| K153608 | Vitoss BiModal Bone Graft Substitute Foam StripMQV · Special | 02/12/2016SE |
| K153306 | Imbibe NeedleKNW · Special | 12/18/2015SE |
| K140868 | Stryker Kwic NeedleHAW · Traditional | 06/05/2014SE |
| K140414 | Imbibe NeedleLXH · Traditional | 04/01/2014SE |
| K103173 | Vitoss Ba Bimodal Bioactive Bone Graft SubstituteMQV · Special | 02/07/2011SE |
| K101171 | Orthovita PEEK SpacerODP · Traditional | 01/25/2011SE |
| K102545 | FM-02 Bone Graft SubstituteMQV · Special | 10/27/2010SE |
| K091618 | VitomatrixLYC · Traditional | 09/27/2010SE |
Questions and answers
When was Orthovita Biogran cleared by the FDA?
Orthovita Biogran (K941780) received a 510(k) decision of Substantially Equivalent on February 10, 1995, 301 days after the submission was received.
What is the product code of K941780?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.