Composi-Tight®
3D Fusion™ Sectional Matrix System: (70) Full Curve Matrices, (80) Wedges, (4) FenderWedge®, (12) Rally™ Polishers, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring, (1)…
3D Fusion™ Sectional Matrix System: (70) Full Curve Matrices, (80) Wedges, (4) FenderWedge®, (12) Rally™ Polishers, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring, (1) Ring Placement Forceps, (1) Matrix Forceps, (1) Multi-Function Instrument
13manufacturers in China registered for this device type
172catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (6), Jiangsu (3), Guangdong (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Tessy Plastics Shanghai Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | Cangzhou | Hebei | Manufacturer | 40 |
| Astar Orthodontics Inc. | Shanghai | Shanghai | Manufacturer | 12 |
Showing 12 of 13. All 13 manufacturers in China registered for Retainer, Matrix
Record
| Listed by | Garrison Dental Solutions, L.L.C. |
|---|---|
| FDA product code | JEP |
| Device type | Retainer, Matrix |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2020-04-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Fx600 of 2, g200 of 3, fx400 of 2, 3d500 of 2, c500 of 3, au500-m of 2 |
| Sizes | Height 4.3 to 6.8 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MC175 | Height 5.9 mm | 100 | In distribution |
| FXR-KFF-10 | In distribution | ||
| 3D-MSF-00 | In distribution | ||
| UN25 | In distribution | ||
| FXB01 | In distribution | ||
| FX175-E | Extended Height 5.6 Millimeter | 10 | In distribution |
| AU050-M | Extended Height 4.2 Millimeter | 25 | In distribution |
| FXH300 | Extended Height 7.7 Millimeter | 100 | In distribution |
| FX-KFF-40-X | In distribution | ||
| AU500-B | In distribution | ||
| AU100-B | Height 4.6 mm | 25 | In distribution |
| FX-DFF-0B | In distribution | ||
| FXR-KHF-10 | In distribution | ||
| FXR01 | In distribution | ||
| UN34 | In distribution | ||
| MC100-M | Height 5.0 mm | 50 | In distribution |
| CE-M01 | In distribution | ||
| B050 | Extended Height 4.2 Millimeter | 50 | In distribution |
| B100-M | Height 4.6 mm | 50 | In distribution |
| AU300-M | Extended Height 8.6 Millimeter | 25 | In distribution |
| FX-MFF-00 | In distribution | ||
| UN14 | In distribution | ||
| AU200 | Height 6.4 mm | 100 | In distribution |
| M200-M | Height 6.4 mm | 50 | In distribution |
| FXHB04 | In distribution | ||
| FX-KFF-04 | In distribution | ||
| 3D-KSA-00 | In distribution | ||
| FXHB03 | In distribution | ||
| FXHB02 | In distribution | ||
| MK3DW-J2 | In distribution | ||
| FX-KFF-40 | In distribution | ||
| B300-M | Extended Height 8.6 Millimeter | 25 | In distribution |
| M200 | Height 6.4 mm | 100 | In distribution |
| M100 | Height 4.6 mm | 100 | In distribution |
| UN28 | In distribution | ||
| UN31 | In distribution | ||
| 3D-KSW-40 | In distribution | ||
| K102 | In distribution | ||
| 3DX-KFF-10 | In distribution | ||
| FX-KFF-00 | In distribution | ||
| 3D-KSF-35 | In distribution | ||
| FXH175 | Height 5.3 mm | 100 | In distribution |
| FX600-1 | In distribution | ||
| 3D-KSW-35 | In distribution | ||
| MC200-M | Height 6.8 mm | 50 | In distribution |
| G200-1 | In distribution | ||
| FX175-M | Extended Height 5.6 Millimeter | 50 | In distribution |
| UN18 | In distribution | ||
| 3D-KFF-10 | In distribution | ||
| B050-M | Extended Height 4.2 Millimeter | 25 | In distribution |
| FX300 | Extended Height 8.7 Millimeter | 60 | In distribution |
| FXH200 | Height 6.1 mm | 100 | In distribution |
| M050 | Extended Height 4.2 Millimeter | 50 | In distribution |
| MC200 | Height 6.8 mm | 100 | In distribution |
| MC175-M | Height 5.9 mm | 50 | In distribution |
| 3D-KCC-00 | In distribution | ||
| FX400-1 | In distribution | ||
| FX-HHF-40 | In distribution | ||
| FXH100-M | Height 4.3 mm | 50 | In distribution |
| B300 | Extended Height 8.6 Millimeter | 50 | In distribution |
| FXR-KFF-11 | In distribution | ||
| 3D-KCC-10 | In distribution | ||
| FX-KHF-00 | In distribution | ||
| B200-M | Height 6.4 mm | 50 | In distribution |
| AU150-B | Extended Height 5.4 Millimeter | 15 | In distribution |
| 3D500-1 | In distribution | ||
| 3D-FSW-00 | In distribution | ||
| C500-1 | In distribution | ||
| FX-KHF-40 | In distribution | ||
| 3D-KSW-00 | In distribution | ||
| UN13 | In distribution | ||
| AU500-1 | In distribution | ||
| FXHBS02 | In distribution | ||
| G100-1 | In distribution | ||
| UN11 | In distribution | ||
| 3DXR-1 | In distribution | ||
| FX-KFF-01 | In distribution | ||
| UN22 | In distribution | ||
| FXH150 | Extended Height 5.9 Millimeter | 100 | In distribution |
| 3D-KSA-10 | In distribution | ||
| FX150-M | Extended Height 6.0 Millimeter | 30 | In distribution |
| UN29 | In distribution | ||
| 3D-KSW-10 | In distribution | ||
| FXH175-M | Height 5.3 mm | 50 | In distribution |
| FX-KFF-50-X | In distribution | ||
| UN15 | In distribution | ||
| AU050 | Extended Height 4.2 Millimeter | 50 | In distribution |
| AU400-1 | In distribution | ||
| B200 | Height 6.4 mm | 100 | In distribution |
| FX200-M | Extended Height 6.6 Millimeter | 50 | In distribution |
| FX175 | Extended Height 5.6 Millimeter | 100 | In distribution |
| FXB02 | In distribution | ||
| B100 | Height 4.6 mm | 100 | In distribution |
| 3D-KSW-01 | In distribution | ||
| FXH150-M | Extended Height 5.9 Millimeter | 50 | In distribution |
| FXH300-M | Extended Height 7.7 Millimeter | 50 | In distribution |
| 3DB-KFF-00 | In distribution | ||
| FXR-HHF-10 | In distribution | ||
| 3D-KCC-11 | In distribution | ||
| M300-M | Extended Height 8.6 Millimeter | 25 | In distribution |
| 3D-KFF-00 | In distribution | ||
| UN26 | In distribution | ||
| FXH200-M | Height 6.1 mm | 50 | In distribution |
| FX200 | Extended Height 6.6 Millimeter | 100 | In distribution |
| AU050-B | Extended Height 4.2 Millimeter | 15 | In distribution |
| 3DX-KSW-00 | In distribution | ||
| FX300-E | Extended Height 8.7 Millimeter | 10 | In distribution |
| 3D-KSF-35-X | In distribution | ||
| 3D400-1 | In distribution | ||
| M100-M | Height 4.6 mm | 50 | In distribution |
| FXHB01 | In distribution | ||
| M175-M | Height 5.5 mm | 50 | In distribution |
| M175 | Height 5.5 mm | 100 | In distribution |
| AU150-M | Extended Height 5.4 Millimeter | 25 | In distribution |
| 3D600-1 | In distribution | ||
| AU100 | Height 4.6 mm | 100 | In distribution |
| AU400-B | In distribution | ||
| M150 | Extended Height 5.4 Millimeter | 50 | In distribution |
| FX100-E | Extended Height 4.4 Millimeter | 10 | In distribution |
| FX-KFF-50 | In distribution | ||
| 3D-MFF-00 | In distribution | ||
| FX-KFF-35-X | In distribution | ||
| M050-M | Extended Height 4.2 Millimeter | 25 | In distribution |
| FXHB05 | In distribution | ||
| 3D-JCC-00 | In distribution | ||
| FXBS01 | In distribution | ||
| UN10 | In distribution | ||
| FX-HHF-00 | In distribution | ||
| AU200-M | Height 6.4 mm | 50 | In distribution |
| FXHBS01 | In distribution | ||
| FX100-M | Extended Height 4.4 Millimeter | 50 | In distribution |
| 3D-KMW-00 | In distribution | ||
| FX300-M | Extended Height 8.7 Millimeter | 30 | In distribution |
| FX-KFF-14 | In distribution | ||
| UN32 | In distribution | ||
| AU300 | Extended Height 8.6 Millimeter | 50 | In distribution |
| AU200-B | Height 6.4 mm | 25 | In distribution |
| FX-KFF-35 | In distribution | ||
| FXH100 | Height 4.3 mm | 100 | In distribution |
| AU100-M | Height 4.6 mm | 50 | In distribution |
| UN20 | In distribution | ||
| B150 | Extended Height 5.4 Millimeter | 50 | In distribution |
| AUK2 | In distribution | ||
| UN27 | In distribution | ||
| M300 | Extended Height 8.6 Millimeter | 50 | In distribution |
| 3D-MSW-00 | In distribution | ||
| MBRP-100 | In distribution | ||
| 3D-KSA-11 | In distribution | ||
| FX-KFF-11 | In distribution | ||
| FX150 | Extended Height 6.0 Millimeter | 60 | In distribution |
| FX-KFF-10 | In distribution | ||
| C400-1 | In distribution | ||
| FX200-E | Extended Height 6.6 Millimeter | 10 | In distribution |
| FX100 | Extended Height 4.4 Millimeter | 100 | In distribution |
| 3D-KSF-10 | In distribution | ||
| M150-M | Extended Height 5.4 Millimeter | 25 | In distribution |
| UN17 | In distribution | ||
| FXHB06 | In distribution | ||
| AU300-B | Extended Height 8.6 Millimeter | 15 | In distribution |
| FX500-1 | In distribution | ||
| 3D-KSW-11 | In distribution | ||
| UN21 | In distribution | ||
| FXR-KFF-14 | In distribution | ||
| 3D-KSW-40-X | In distribution | ||
| UN30 | In distribution | ||
| FX150-E | Extended Height 6.0 Millimeter | 10 | In distribution |
| 3D-KSW-35-X | In distribution | ||
| AU150 | Extended Height 5.4 Millimeter | 50 | In distribution |
| FX-MFF-10 | In distribution | ||
| FX-DFF-0A | In distribution | ||
| MC100 | Height 5.0 mm | 100 | In distribution |
| B150-M | Extended Height 5.4 Millimeter | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bioclear Evolve | Bioclear Matrix Systems, LLC | 54 |
| Slick Bands™ | Garrison Dental Solutions, L.L.C. | 52 |
| Henry Schein | Henry Schein, Inc. | 47 |
| Halo Sectional Matrix System | Ultradent Products Inc. | 44 |
| Black Triangle Matrix | Bioclear Matrix Systems, LLC | 42 |
| HD Anterior Matrix A Series | Bioclear Matrix Systems, LLC | 37 |
| Strata-G™ | Garrison Dental Solutions, L.L.C. | 33 |
| NiTin Garrison® | Garrison Dental Solutions, L.L.C. | 33 |
| White Bite | White Bite, Inc. | 30 |
| Denovo Preformed Matrix Band | Denovo Dental Inc | 30 |
| Quad Matrix System™ | Garrison Dental Solutions, L.L.C. | 26 |
| Original Anterior Matrix A Series | Bioclear Matrix Systems, LLC | 25 |
Showing 12 of 102. All products under Retainer, Matrix
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.