Straumann BoneCeramic
FDA 510(k) K201051 · Institut Straumann AG
510(k) numberK201051
Submission
- Device name
- Straumann BoneCeramic
- Applicant
- Institut Straumann AG
Basel, CH - Received
- April 21, 2020
- Decision date
- September 24, 2020
- 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 |
| K192597 | Cytrans GranulesLYC · Abbreviated | GC America, Inc. | 08/17/2020SE |
More from GC America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260726 | Straumann® ProClean Cassette (041.800 ; 041.801)KCT · Traditional | 06/03/2026SE |
| K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueNHA · Traditional | 05/07/2026SE |
| K252168 | Straumann® BLC Implants - Indication WideningDZE · Traditional | 03/10/2026SE |
| K253315 | Straumann Variobase Abutments XC for Bridge/BarNHA · Traditional | 01/22/2026SE |
| K250294 | Straumann® RidgeFit ImplantsDZE · Traditional | 08/12/2025SE |
| K243278 | Custom AbutmentsNHA · Traditional | 02/21/2025SE |
| K243478 | Straumann InLab Validated WorkflowNHA · Traditional | 02/19/2025SE |
| K233252 | Straumann CARES Visual and Nova Dental CADPNP · Traditional | 12/26/2024SE |
| K241391 | Straumann® PURE Ceramic ImplantsDZE · Traditional | 12/10/2024SE |
| K234049 | Straumann® BLC and TLC Implants - Line extensionDZE · Traditional | 03/20/2024SE |
Questions and answers
When was Straumann BoneCeramic cleared by the FDA?
Straumann BoneCeramic (K201051) received a 510(k) decision of Substantially Equivalent on September 24, 2020, 156 days after the submission was received.
What is the product code of K201051?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.