Restorative System
Restorative Instrumentation System Everything you need to restore our entire line of two-stage implants A system that contains all instrumentation needed to restore our entire line of two…
Restorative Instrumentation System Everything you need to restore our entire line of two-stage implants A system that contains all instrumentation needed to restore our entire line of two stage dental implants; including the TSI, ERI, Engage™ and Macro™. All components are labeled for easy removal and return to the tray after autoclaving for sterilization.
Who Else Makes It
Concentrated in Hebei (4), Shanghai (3), Guangdong (2). 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 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| 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 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | Cangzhou | Hebei | Manufacturer | 40 |
| Huanghua DK Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 37 |
Record
| Listed by | OCO Biomedical, United States |
|---|---|
| FDA product code | EIL |
| Device type | Gauge, Depth, Instrument, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-04-21 |
| Record revised | 2024-02-13 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2021-10-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Restorative Instrumentation System | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endoring | Jordco, Inc. | 41 |
| Dental Instrument | Cowellmedi Co., Ltd. | 36 |
| Surgical Direct | Surgical Direct, Inc. | 29 |
| Biotem | Biotem Co., Ltd. | 26 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 24 |
| EdgeVerify | US Endodontics, LLC | 24 |
| ACE | Ace Surgical Supply Co., Inc. | 16 |
| devemed | Devemed Gmbh | 13 |
| Genesis | Keystone Dental Inc. | 12 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 12 |
| Reicodent | Devemed Gmbh | 12 |
| ID-Ring | Diadent Group Intl., Inc. | 11 |
Showing 12 of 126. All products under Gauge, Depth, Instrument, 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.