Gentle Pulse™
Ground Clip Lead Wire & Adaptor for Gentle Pulse™ & Digitest™ Pulptesters (Complies with New FDA Lead Wire Regulation)
2manufacturers in China registered for this device type
11catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Parkell, Inc., United States |
|---|---|
| FDA product code | EAT |
| Device type | Tester, Pulp |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1720 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2018-10-11 (version 3) |
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, serial number |
| Storage | Storage environment temperature -18 to 40 °C |
| Distribution end date | 2025-01-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D631GC | In distribution | |
| D636-K | In distribution | |
| D625-K | In distribution | |
| D631ADAPT | In distribution | |
| D625 | In distribution | |
| D636 | In distribution | |
| D624MSCR | Withdrawn | |
| D624MSE-K | Withdrawn | |
| D624MS | Withdrawn | |
| D624MS | Withdrawn | |
| D624MSE | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Patterson | Patterson Dental Supply, Inc. | 2 |
Showing 12 of 72. All products under Tester, Pulp
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K022097 | 2002-09-06 |
| K950237 | 1995-06-09 |
| K950238 | 1995-05-09 |
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.