EdgeIce
EdgeIce Refrigerant pulp vitality spray is used in dentistry for the purpose of thermo testing of tooth vitality. For professional dental use only.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangxi (1), Hunan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
Record
| Listed by | Edge Endo LLC |
|---|---|
| FDA product code | EAT |
| Device type | Tester, Pulp |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1720 |
| Premarket notification | Exempt |
| Record published | 2017-09-28 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Weight 170 g |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EDGEICE | Weight 170 g | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Gentle Pulse™ | Parkell, Inc. | 11 |
| Touch ‘n Heat | Kerr Corporation | 9 |
| Digitest™ | Parkell, Inc. | 8 |
| Vitality Scanner | Kerr Corporation | 7 |
| Thermique™ | Parkell, Inc. | 6 |
| Buchanan Plugger | Ormco Corporation | 6 |
| Tester, Pulp | Parkell, Inc. | 6 |
| Elements | Ormco Corporation | 5 |
| Heat Carrier | Ormco Corporation | 4 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 2 |
| Elements | Kerr Corporation | 2 |
| CanalPro | Coltene/Whaledent Gmbh & Co. KG | 2 |
Showing 12 of 72. All products under Tester, Pulp
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.