Product code EAT
- Device name
- Tester, Pulp
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.1720
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K022097 | THERMIQUE | Parkell, Inc. | 2002-09-06 |
| K021298 | ELEMENTS DIAGNOSTIC UNIT | Sybron Endo/Analytic | 2002-06-19 |
| K012427 | PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT | Specialites Septodont | 2001-10-09 |
| K011666 | CHILLIT | Heatshield, Inc. | 2001-08-06 |
| K990225 | ENDO ANALYZER, MODEL 8005, MODIFIED | Sybron Dental Specialties, Inc. | 1999-02-25 |
| K973439 | ENDO ANALYZER, MODEL 8005 | Sybron Dental Specialties, Inc. | 1997-12-08 |
| K970715 | SYSTEM B HEAT SOURCE | Sybron Dental Specialties, Inc. | 1997-04-07 |
| K963862 | TOUCH N' HEAT | Sybron Dental Specialties, Inc. | 1996-12-02 |
| K960799 | ORTHO-ICE | Ultimate Wireforms, Inc. | 1996-05-09 |
| K950237 | DIGITEST | Parkell, Inc. | 1995-06-09 |
| K950238 | GENTAL PULSE | Parkell, Inc. | 1995-05-09 |
| K940260 | THERMAL PULP TESTER | Union Broach, Div. Moyco Industries, Inc. | 1994-03-07 |
| K930764 | ENDO-ICE-PULP TESTER-THERMAL | The Hygenic Corp. | 1993-05-27 |
| K883804 | E-MITT (CONDUCTIVE HAND COVER) | The Institute For Technology Development | 1989-07-31 |
| K881826 | ENDO-ICE | The Hygenic Corp. | 1988-08-23 |
| K872039 | MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS | Life-Tech Intl., Inc. | 1987-11-13 |
| K873644 | PULP PEN | The Hygenic Corp. | 1987-10-27 |
| K870118 | MODEL 6110B DENTAPHOR | Life-Tech Intl., Inc. | 1987-04-10 |
| K830105 | VITATHYL | North Pacific Dental, Inc. | 1983-03-01 |
| K820598 | HOT & COLD PULP TESTER #4001 | Analytic Technology | 1982-03-19 |
| K800138 | TS-301 THREE-WAY PULP TESTER | Tamler-Stoneham Instruments | 1980-02-13 |
| K790799 | PULPTESTER MODEL 2001 | Analytic Technology | 1979-05-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00371347019902 | Advance Dental Products | The Atlanta Dental Supply Company | 2026-04-16 |
| 00840016202056 | CanalPro | COLTENE/WHALEDENT INC | 2026-02-10 |
| 00850080491027 | Advance Dental Products | ECOTEC MANUFACTURING, INC. | 2025-10-21 |
| 00850080491003 | Marie Reiko | ECOTEC MANUFACTURING, INC. | 2025-10-13 |
| 00850080491010 | Marie Reiko | ECOTEC MANUFACTURING, INC. | 2025-10-13 |
| 00810000521029 | Digitest™ | PARKELL, INC. | 2022-12-23 |
| 00371347008128 | Advance Dental Products | The Atlanta Dental Supply Company | 2022-12-07 |
| 00195062037283 | Vitality Scanner | Kerr Corporation | 2021-03-05 |
| 00195062031083 | Bifurcated Probe | Kerr Corporation | 2021-03-05 |
| 00195062031076 | Vitality Probe | Kerr Corporation | 2021-03-05 |
| 00195062031069 | Crown Test Tip | Kerr Corporation | 2021-03-05 |
| 00195062030123 | Vitality Scanner | Kerr Corporation | 2021-03-05 |
| 00195062030116 | Vitality Scanner | Kerr Corporation | 2021-03-05 |
| 00195062030109 | Vitality Scanner | Kerr Corporation | 2021-03-05 |
| 00195062030093 | Vitality Scanner | Kerr Corporation | 2021-03-05 |
| 00195062031052 | Lip Hook | Kerr Corporation | 2021-03-05 |
| 00810000520480 | Gentle Pulse™ | PARKELL, INC. | 2018-09-14 |
| 00366975010827 | BENCO | BENCO DENTAL SUPPLY CO. | 2017-11-13 |
| D77810650320 | ENDO-SAVER ICE REFRIGERANT SPRAY 10oz CAN | SCOTT'S DENTAL SUPPLY L.L.C. | 2017-06-02 |
| D773330100051 | Health-Tec Endo Refrigerant Spray | Dental Health Products Inc | 2017-01-17 |
| H65811250560 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| D6620708470040 | PATTERSON | PATTERSON DENTAL SUPPLY, INC. | 2016-09-23 |
| D6620704704430 | PATTERSON | PATTERSON DENTAL SUPPLY, INC. | 2016-09-23 |
| M595D626DGC0 | Digitest™ | PARKELL, INC. | 2016-09-23 |
| M595D625S1 | NA | PARKELL, INC. | 2016-09-23 |
| M595D631GC0 | NA | PARKELL, INC. | 2016-09-23 |
| M595D624MSCR0 | Gentle Pulse™ | PARKELL, INC. | 2016-09-23 |
| M595D640CR0 | Digitest™ | PARKELL, INC. | 2016-09-23 |
| D72310285503 | Chill™ refrigerant spray | SAFCO DENTAL SUPPLY CO. | 2016-08-12 |
| D661H050320 | Hygenic | COLTENE/WHALEDENT INC | 2016-06-17 |