EAT · Tester, Pulp
Dental · 21 CFR 872.1720 · Class 2
Overview
| Product Code | EAT |
|---|---|
| Device Name | Tester, Pulp |
| Regulation | 21 CFR 872.1720 |
| Device Class | Class 2 |
| Review Panel | Dental |
Identification
A pulp tester is an AC or battery powered device intended to evaluate the pulpal vitality of teeth by employing high frequency current transmitted by an electrode to stimulate the nerve tissue in the dental pulp.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (20 of 22)
Showing 20 most recent of 22 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K022097 | THERMIQUE | Parkell, Inc. | Sep 6, 2002 | SESE |
| K021298 | ELEMENTS DIAGNOSTIC UNIT | Sybron Endo/Analytic | Jun 19, 2002 | SESE |
| K012427 | PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT | Specialites Septodont | Oct 9, 2001 | SESE |
| K011666 | CHILLIT | Heatshield, Inc. | Aug 6, 2001 | SESE |
| K990225 | ENDO ANALYZER, MODEL 8005, MODIFIED | Sybron Dental Specialties, Inc. | Feb 25, 1999 | SESE |
| K973439 | ENDO ANALYZER, MODEL 8005 | Sybron Dental Specialties, Inc. | Dec 8, 1997 | SESE |
| K970715 | SYSTEM B HEAT SOURCE | Sybron Dental Specialties, Inc. | Apr 7, 1997 | SESE |
| K963862 | TOUCH N' HEAT | Sybron Dental Specialties, Inc. | Dec 2, 1996 | SESE |
| K960799 | ORTHO-ICE | Ultimate Wireforms, Inc. | May 9, 1996 | SESE |
| K950237 | DIGITEST | Parkell, Inc. | Jun 9, 1995 | SESE |
| K950238 | GENTAL PULSE | Parkell, Inc. | May 9, 1995 | SESE |
| K940260 | THERMAL PULP TESTER | Union Broach, Div. Moyco Industries, Inc. | Mar 7, 1994 | SESE |
| K930764 | ENDO-ICE-PULP TESTER-THERMAL | The Hygenic Corp. | May 27, 1993 | SESE |
| K883804 | E-MITT (CONDUCTIVE HAND COVER) | The Institute For Technology Development | Jul 31, 1989 | SESE |
| K881826 | ENDO-ICE | The Hygenic Corp. | Aug 23, 1988 | SN |
| K872039 | MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS | Life-Tech Intl., Inc. | Nov 13, 1987 | SESE |
| K873644 | PULP PEN | The Hygenic Corp. | Oct 27, 1987 | SESE |
| K870118 | MODEL 6110B DENTAPHOR | Life-Tech Intl., Inc. | Apr 10, 1987 | SESE |
| K830105 | VITATHYL | North Pacific Dental, Inc. | Mar 1, 1983 | SESE |
| K820598 | HOT & COLD PULP TESTER #4001 | Analytic Technology | Mar 19, 1982 | SESE |
Top Applicants
- Sybron Dental Specialties, Inc. — 4 clearances
- The Hygenic Corp. — 3 clearances
- Parkell, Inc. — 3 clearances
- Life-Tech Intl., Inc. — 2 clearances
- Analytic Technology — 2 clearances
