Unigrafe
FDA 510(k) K982699 · Unicare Biomedical
510(k) numberK982699
Submission
- Device name
- Unigrafe
- Applicant
- Unicare Biomedical
Laguna Hills, CA, US - Received
- August 3, 1998
- Decision date
- October 20, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K151344 | Cytoflex Tefguard Ti-Enforced MembraneNPK · Traditional | 11/19/2015SE |
| K092567 | Modification to UnigraftLYC · Traditional | 11/25/2009SE |
| K090612 | BenacelOLR · Traditional | 07/24/2009SE |
| K090083 | Cytoflex Resorb, Model C03-0010 Through C03-090LYC · Traditional | 03/23/2009SE |
| K080532 | Benacel, Models C-001, C-002 and C-005QSY · Traditional | 11/12/2008SE |
| K021511 | Cytoflex MeshJEY · Traditional | 08/06/2002SE |
| K020720 | OssiformLYC · Traditional | 05/07/2002SE |
| K012144 | CytoflexLYC · Traditional | 10/01/2001SE |
| K003457 | UnigraftLYC · Traditional | 01/09/2001SE |
| K993784 | UnigraftLYC · Traditional | 01/27/2000SE |
Questions and answers
When was Unigrafe cleared by the FDA?
Unigrafe (K982699) received a 510(k) decision of Substantially Equivalent on October 20, 1998, 78 days after the submission was received.
What is the product code of K982699?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.