Tester, Pulp
FDA product code EAT · Class II (moderate risk) · 21 CFR 872.1720 · Dental
22510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Sybron Dental Specialties, Inc. 4
- The Hygenic Corp. 3
- Parkell, Inc. 3
- Analytic Technology 2
- Life-Tech Intl., Inc. 2
- Tamler-Stoneham Instruments 1
- North Pacific Dental, Inc. 1
- The Institute For Technology Development 1
- Union Broach, Div. Moyco Industries, Inc. 1
- Ultimate Wireforms, Inc. 1
- Heatshield, Inc. 1
- Specialites Septodont 1
- Sybron Endo/Analytic 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022097 | ThermiqueEAT · Traditional | Parkell, Inc. | 09/06/2002SE |
| K021298 | Elements Diagnostic UnitEAT · Traditional | Sybron Endo/Analytic | 06/19/2002SE |
| K012427 | Pharmaethyl Local Pulp and Vitality Testing AgentEAT · Traditional | Specialites Septodont | 10/09/2001SE |
| K011666 | ChillitEAT · Traditional | Heatshield, Inc. | 08/06/2001SE |
| K990225 | Endo Analyzer, Model 8005, ModifiedEAT · Traditional | Sybron Dental Specialties, Inc. | 02/25/1999SE |
| K973439 | Endo Analyzer, Model 8005EAT · Traditional | Sybron Dental Specialties, Inc. | 12/08/1997SE |
| K970715 | System B Heat SourceEAT · Traditional | Sybron Dental Specialties, Inc. | 04/07/1997SE |
| K963862 | Touch N' HeatEAT · Traditional | Sybron Dental Specialties, Inc. | 12/02/1996SE |
| K960799 | Ortho-IceEAT · Traditional | Ultimate Wireforms, Inc. | 05/09/1996SE |
| K950237 | DigitestEAT · Traditional | Parkell, Inc. | 06/09/1995SE |
| K950238 | Gental PulseEAT · Traditional | Parkell, Inc. | 05/09/1995SE |
| K940260 | Thermal Pulp TesterEAT · Traditional | Union Broach, Div. Moyco Industries, Inc. | 03/07/1994SE |
| K930764 | Endo-Ice-Pulp Tester-ThermalEAT · Traditional | The Hygenic Corp. | 05/27/1993SE |
| K883804 | E-Mitt (Conductive Hand Cover)EAT · Traditional | The Institute For Technology Development | 07/31/1989SE |
| K881826 | Endo-IceEAT · Traditional | The Hygenic Corp. | 08/23/1988SN |
| K872039 | Model SK-14 Starter Kit for Dental IontophoresisEAT · Traditional | Life-Tech Intl., Inc. | 11/13/1987SE |
| K873644 | Pulp PenEAT · Traditional | The Hygenic Corp. | 10/27/1987SE |
| K870118 | Model 6110B DentaphorEAT · Traditional | Life-Tech Intl., Inc. | 04/10/1987SE |
| K830105 | VitathylEAT · Traditional | North Pacific Dental, Inc. | 03/01/1983SE |
| K820598 | Hot & Cold Pulp Tester #4001EAT · Traditional | Analytic Technology | 03/19/1982SE |
| K800138 | TS-301 Three-Way Pulp TesterEAT · Traditional | Tamler-Stoneham Instruments | 02/13/1980SE |
| K790799 | Pulptester Model 2001EAT · Traditional | Analytic Technology | 05/31/1979SE |