SMARTbuilder System (SB1)
SMARTbuilder SB1 is a preformed titanium membrane that supports and stabilizes bone graft in oral bone-defect sites. It is used with a compatible dental implant as part of alveolar bone…
SMARTbuilder SB1 is a preformed titanium membrane that supports and stabilizes bone graft in oral bone-defect sites. It is used with a compatible dental implant as part of alveolar bone augmentation.
The nonabsorbable membrane is made from commercially pure Grade 2 titanium. Its three-dimensional, scalloped form and different dimensions accommodate the grafted region.
Membrane Configuration
The family offers different proximal widths and buccal or lingual dimensions to suit the defect. The membrane is supplied sterile and is used with specified compatible Osstem implant systems. It forms the metal support around the grafted space while the dental implant provides the associated fixation interface.
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Kontour (Xi’an) Medical Technology Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 4 |
Record
| Listed by | Osstem Implant Co., Ltd., South Korea |
|---|---|
| FDA product code | JEY |
| Device type | Plate, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4760 |
| Establishment | Contract manufacturer, Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K130840 |
| Record published | 2015-10-16 |
| Record revised | 2023-08-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SB1P103A | In distribution | |
| SM2W7127SE | In distribution | |
| SM2W7129SE | In distribution | |
| SB1P73A | In distribution | |
| SB1P105A | In distribution | |
| SB1P75A | In distribution | |
| SB1P123A | In distribution | |
| SM2W599SE | In distribution | |
| SM2W6127SE | In distribution | |
| SM2W6129SE | In distribution | |
| SB1P125A | In distribution | |
| SM2W597SE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Plate, Bone | Stryker Leibinger Gmbh & Co. KG | 1,338 |
| Level ONE CMF | KLS-Martin L.P. | 1,160 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 843 |
| OsteoMed | Osteomed | 675 |
| Bioplate® | Bioplate, Inc. | 669 |
| Plate, Bone | Synthes Gmbh | 568 |
| Leforte System Bone Plate | Jeil Medical Corporation | 466 |
| CMF Visionare | Visionare LLC | 421 |
| Level ONE CMF, Sterile | KLS-Martin L.P. | 416 |
| Faico CMF System | Faico Medical, LLC | 361 |
| TraumaOne System | Biomet Microfixation | 357 |
| MatrixMANDIBLE | Synthes Gmbh | 277 |
Showing 12 of 152. All products under Plate, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172354 | 2018-03-26 |
| K130840 | 2013-09-18 |
| K120951 | 2012-10-03 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.