FDA product code EAT: Tester, Pulp
EAT is the FDA product code for tester, pulp. It is a Class II device, regulated under 21 CFR 872.1720 and reviewed by the Dental panel. FDA has cleared 22 510(k) submissions under EAT, from 13 different applicants. The average 510(k) review took 83 days (median 70).
Classification
| Field | Value |
|---|---|
| Device name | Tester, Pulp |
| Device class | Class II |
| Regulation | 21 CFR 872.1720 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EAT clearance
Top EAT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sybron Dental Specialties, Inc. | 4 | 1999-02-25 |
| Parkell, Inc. | 3 | 2002-09-06 |
| The Hygenic Corp. | 3 | 1993-05-27 |
| Life-Tech Intl., Inc. | 2 | 1987-11-13 |
| Analytic Technology | 2 | 1982-03-19 |
8 more applicants have EAT clearances. See the full list in Caduvo.
Most recent EAT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022097 | Parkell, Inc. | THERMIQUE | 2002-09-06 | 71 |
| K021298 | Sybron Endo/Analytic | ELEMENTS DIAGNOSTIC UNIT | 2002-06-19 | 56 |
| K012427 | Specialites Septodont | PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT | 2001-10-09 | 70 |
| K011666 | Heatshield, Inc. | CHILLIT | 2001-08-06 | 68 |
| K990225 | Sybron Dental Specialties, Inc. | ENDO ANALYZER, MODEL 8005, MODIFIED | 1999-02-25 | 31 |
Recalls for EAT devices
openFDA lists no recalls for product code EAT.
Frequently asked questions
What is FDA product code EAT?
EAT is the FDA product code for tester, pulp. It is a Class II device, regulated under 21 CFR 872.1720 and reviewed by the Dental panel.
What device class is EAT?
Class II, regulation 21 CFR 872.1720. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EAT?
Across 22 cleared submissions the average was 83 days from receipt to decision (median 70).
Which companies have the most EAT clearances?
Sybron Dental Specialties, Inc. (4); Parkell, Inc. (3); The Hygenic Corp. (3); Life-Tech Intl., Inc. (2); Analytic Technology (2).
Next steps
- Run an FDA pathway report with predicate devices for product code EAT
- Run a recall and safety report across every EAT manufacturer
- Watch product code EAT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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