NiTin™
Sectional Matrix Kit with Full Curve Metal Bands: (100) Full Curve Matrices, (100) Wedges, (1) NT400 Ring, (1) NT500 Ring, (1) Gold Handle Ring Placement Forceps, (1) Band Forceps
13manufacturers in China registered for this device type
21catalogue 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 | Nt400 of 2, nt500 of 2 |
| Sizes | Height 4 to 5.4 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| NTM150-M | Extended Height 4.1 Millimeter | 25 | In distribution |
| NT-KMN-01-X | In distribution | ||
| NT-KMN-35 | In distribution | ||
| NTM200-M | Height 5.4 mm | 25 | In distribution |
| NT-KMN-40 | In distribution | ||
| NTR01 | In distribution | ||
| NTM150 | Extended Height 4.1 Millimeter | 50 | In distribution |
| NTMK01 | In distribution | ||
| NT-KMN-01 | In distribution | ||
| NT-KMN-40-X | In distribution | ||
| NTM100-M | Height 4.0 mm | 25 | In distribution |
| NTM175 | Height 5.0 mm | 50 | In distribution |
| NTM175-M | Height 5.0 mm | 25 | In distribution |
| NT-KMN-35-X | In distribution | ||
| NTM100 | Height 4.0 mm | 50 | In distribution |
| NT400-1 | In distribution | ||
| NTM300-M | Extended Height 6.0 Millimeter | 25 | In distribution |
| NT-MMN-00 | In distribution | ||
| NTM200 | Height 5.4 mm | 50 | In distribution |
| NTM300 | Extended Height 6.0 Millimeter | 50 | In distribution |
| NT500-1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Composi-Tight® | Garrison Dental Solutions, L.L.C. | 172 |
| 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 |
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.