Diagnostic devices · 21 CFR 872 Subpart B
Pulp Tester
FDA device type “Tester, Pulp”.
- Companies listing it
- 209 makers
- Brands and models
- 25
- 510(k) clearances
- 220 in five years
- FDA name
- Tester, Pulp
510(k) clearances per year, 1976–2026
Companies that list EAT
20 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | China | Maker | Ai-Pex | 12 | 2025 |
| Sybron Dental Specialties | United States | Maker | Apex Locator · Buchanan System B Plugger · Elements Diagnostic Unit · Hot Pulp Test Tip · +7 | 203 | 2026 |
| Parkell, Inc | United States | Maker | — | 58 | 2025 |
| Pac-Dent Inc. | United States | Maker | PacEndo Vital Ice 360 Green 1 bottle 6oz · PacEndo Vital Ice 360 Green 12 bottles per case | 5 | 2022 |
| Coltene/Whaledent AG | Switzerland | Maker | Endo X-Move Bundle · ENDO-ICE · ENDO-ICE GREEN | 45 | 2022 |
| Denjoy Dental Co., Ltd. | China | Maker | PULP TESTER | 1 | 2025 |
| B&L Biotech Co., Ltd. | South Korea | Maker | Obtura Spartan Hot Pulp Testing Tip | 1 | 2006 |
| Ecotec Manufacturing | United States | Maker | — | — | — |
| Stoner Incorporated | United States | Maker | — | — | — |
| HSG-S Corp | United States | Manufacturer | EdgeIce | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Endo Ice | — | — |
| Premium Plus Dental | United States | Lister | Premium Plus Dental Supplies Inc | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | MARK3® Endo Pulp Vitality Refrigerant Spray | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | Dyna Ice, Chill Spray, Ortho-Ice | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | — | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| MN Health Inc, | United States | Repacker / relabeler | raypulp | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 6 Sep 2002 | K022097 | THERMIQUE | Parkell, Inc |
| 19 Jun 2002 | K021298 | ELEMENTS DIAGNOSTIC UNIT | Sybron Endo/Analytic |
| 9 Oct 2001 | K012427 | PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT | Specialites Septodont |
| 6 Aug 2001 | K011666 | CHILLIT | Heatshield, Inc. |
| 25 Feb 1999 | K990225 | ENDO ANALYZER, MODEL 8005, MODIFIED | Sybron Dental Specialties |
| 8 Dec 1997 | K973439 | ENDO ANALYZER, MODEL 8005 | Sybron Dental Specialties |
| 7 Apr 1997 | K970715 | SYSTEM B HEAT SOURCE | Sybron Dental Specialties |
| 2 Dec 1996 | K963862 | TOUCH N' HEAT | Sybron Dental Specialties |
| 9 May 1996 | K960799 | ORTHO-ICE | Ultimate Wireforms, Inc. |
| 9 Jun 1995 | K950237 | DIGITEST | Parkell, Inc |
| 9 May 1995 | K950238 | GENTAL PULSE | Parkell, Inc |
| 7 Mar 1994 | K940260 | THERMAL PULP TESTER | Union Broach, Div. Moyco Industries, Inc. |
| 27 May 1993 | K930764 | ENDO-ICE-PULP TESTER-THERMAL | The Hygenic Company, LLC |
| 31 Jul 1989 | K883804 | E-MITT (CONDUCTIVE HAND COVER) | The Institute For Technology Development |
| 23 Aug 1988 | K881826 | ENDO-ICE | The Hygenic Company, LLC |
| 13 Nov 1987 | K872039 | MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS | Life-Tech Intl., Inc. |
| 27 Oct 1987 | K873644 | PULP PEN | The Hygenic Company, LLC |
| 10 Apr 1987 | K870118 | MODEL 6110B DENTAPHOR | Life-Tech Intl., Inc. |
| 1 Mar 1983 | K830105 | VITATHYL | North Pacific Dental, Inc. |
| 19 Mar 1982 | K820598 | HOT & COLD PULP TESTER #4001 | Analytic Technology |
| 13 Feb 1980 | K800138 | TS-301 THREE-WAY PULP TESTER | Tamler-Stoneham Instruments |
| 31 May 1979 | K790799 | PULPTESTER MODEL 2001 | Analytic Technology |
Official records: FDA product classification for EAT · 21 CFR 872.1720.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026