FitStrip™
Universal Kit: (1) IPR Gauge, (4) Single-Sided Strips - 1 of Each 0.08mm, 0.10mm, 0.13mm, 0.18mm, (6) Double-Sided Strips - 1 of Each 0.11mm, 0.15mm, 0.21mm, 0.30mm, 0.40mm, 0.50mm, (2)…
Universal Kit: (1) IPR Gauge, (4) Single-Sided Strips – 1 of Each 0.08mm, 0.10mm, 0.13mm, 0.18mm, (6) Double-Sided Strips – 1 of Each 0.11mm, 0.15mm, 0.21mm, 0.30mm, 0.40mm, 0.50mm, (2) Handles
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (1), Henan (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Huizhou Videya Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 18 |
| Shenzhen Superline Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 12 |
| Shenzhen Forever Medical Devices Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Deprag High Tech Materials ( Zhengzhou ) Co., Ltd. | Zhangzhou | Henan | Manufacturer | 6 |
Record
| Listed by | Garrison Dental Solutions, L.L.C. |
|---|---|
| FDA product code | DZP |
| Device type | Instrument, Diamond, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4535 |
| Premarket notification | Exempt |
| Record published | 2020-04-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Fpsxfss-4 of 4, fpstmds-4 of 4, fpsmss-4 of 4, fpsfss-4 of 4, fpsgxfss-4 of 4, fpscds-4 of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FPSK04 | In distribution | |
| FPSXFSS-1 | In distribution | |
| FPSTMDS-1 | In distribution | |
| FPSXFSS | In distribution | |
| FPSXTMDS | In distribution | |
| FPSMSS-1 | In distribution | |
| FPSMSS | In distribution | |
| FPSGMSS-1 | In distribution | |
| FPSS01 | In distribution | |
| FPSK03 | In distribution | |
| FPSK08 | In distribution | |
| FPSFSS-1 | In distribution | |
| FPSCDS | In distribution | |
| FPSGXFSS | In distribution | |
| FPSS02 | In distribution | |
| FPSCDS-1 | In distribution | |
| FPSGMSS | In distribution | |
| FPSGAUGE | In distribution | |
| FPSTMDS | In distribution | |
| FPSFDS-1 | In distribution | |
| FPSGFSS-1 | In distribution | |
| FPSMDS-1 | In distribution | |
| FPSCSS | In distribution | |
| FPSFSS | In distribution | |
| FPSCSS-1 | In distribution | |
| FPSK03 | In distribution | |
| FPSXTMDS-1 | In distribution | |
| FPSGFSS | In distribution | |
| FPSFDS | In distribution | |
| FPSHANDLE | In distribution | |
| FPSK01 | In distribution | |
| FPSXFDS-1 | In distribution | |
| FPSMDS | In distribution | |
| FPSK07 | In distribution | |
| FPSSAW | In distribution | |
| FPSGXFSS-1 | In distribution | |
| FPSK05 | In distribution | |
| FPSSAW-1 | In distribution | |
| FPSXFDS | In distribution | |
| FPSK02 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MDT Diamond Coated Dental Burs | M.D.T. – Micro Diamond Technologies Ltd. | 31,050 |
| MDT Diamond Coated Dental Burs -Sterile | M.D.T. – Micro Diamond Technologies Ltd. | 3,719 |
| FG diamond | DFS-Diamon Gmbh | 2,527 |
| Horico | Hopf, Ringleb & Co. Gmbh & CIE. | 2,320 |
| Two Striper | Abrasive Technology, LLC | 2,294 |
| Sunshine Diamonds | DR. Hopf Gmbh & Co. KG | 2,240 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 2,016 |
| Edenta | Edenta Etablissement | 1,831 |
| Instrument, Diamond, Dental | Hager & Meisinger Gesellschaft mit beschränkter Haftung | 1,827 |
| Jota | Jota AG | 1,615 |
| Komet Dental Diamond Instruments | Gebr. Brasseler Gmbh & Co. KG | 1,610 |
| dental diamond bur | Strauss & Co – Industrial Diamonds Ltd | 1,456 |
Showing 12 of 366. All products under Instrument, Diamond, Dental
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.