Restore
Tissue Measuring Gauge
10manufacturers in China registered for this device type
5catalogue numbers in this listing
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 | Keystone Dental Inc., United States |
|---|---|
| FDA product code | EIL |
| Device type | Gauge, Depth, Instrument, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2019-05-08 |
| Record revised | 2021-03-25 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| I3280-40K | In distribution | |
| R9185-33K | In distribution | |
| L1803-01K | In distribution | |
| R9118K | In distribution | |
| L1805-01K | In distribution |
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.