EAT — Tester, Pulp Class II
FDA product code EAT covers "Tester, Pulp", a Class II medical device regulated under 21 CFR 872.1720. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EAT
- Device Class
- Class II
- Regulation Number
- 872.1720
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K022097 | parkell | THERMIQUE | September 6, 2002 |
| K021298 | sybron endo/analytic | ELEMENTS DIAGNOSTIC UNIT | June 19, 2002 |
| K012427 | specialites septodont | PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT | October 9, 2001 |
| K011666 | heatshield | CHILLIT | August 6, 2001 |
| K990225 | sybron dental specialties | ENDO ANALYZER, MODEL 8005, MODIFIED | February 25, 1999 |
| K973439 | sybron dental specialties | ENDO ANALYZER, MODEL 8005 | December 8, 1997 |
| K970715 | sybron dental specialties | SYSTEM B HEAT SOURCE | April 7, 1997 |
| K963862 | sybron dental specialties | TOUCH N' HEAT | December 2, 1996 |
| K960799 | ultimate wireforms | ORTHO-ICE | May 9, 1996 |
| K950237 | parkell | DIGITEST | June 9, 1995 |
| K950238 | parkell | GENTAL PULSE | May 9, 1995 |
| K940260 | union broach, div. moyco industries | THERMAL PULP TESTER | March 7, 1994 |
| K930764 | hygenic | ENDO-ICE-PULP TESTER-THERMAL | May 27, 1993 |
| K883804 | institute for technology development | E-MITT (CONDUCTIVE HAND COVER) | July 31, 1989 |
| K881826 | hygenic | ENDO-ICE | August 23, 1988 |
| K872039 | life-tech intl | MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS | November 13, 1987 |
| K873644 | hygenic | PULP PEN | October 27, 1987 |
| K870118 | life-tech intl | MODEL 6110B DENTAPHOR | April 10, 1987 |
| K830105 | north pacific dental | VITATHYL | March 1, 1983 |
| K820598 | analytic technology | HOT & COLD PULP TESTER #4001 | March 19, 1982 |