Pulptester Model 2001
FDA 510(k) K790799 · Analytic Technology
510(k) numberK790799
Submission
- Device name
- Pulptester Model 2001
- Applicant
- Analytic Technology
Mchenry, IL, US - Received
- April 24, 1979
- Decision date
- May 31, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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|---|---|---|---|
| K022097 | ThermiqueEAT · Traditional | Parkell, Inc. | 09/06/2002SE |
| K021298 | Elements Diagnostic UnitEAT · Traditional | Sybron Endo/Analytic | 06/19/2002SE |
| K012427 | Pharmaethyl Local Pulp and Vitality Testing AgentEAT · Traditional | Specialites Septodont | 10/09/2001SE |
| K011666 | ChillitEAT · Traditional | Heatshield, Inc. | 08/06/2001SE |
| K990225 | Endo Analyzer, Model 8005, ModifiedEAT · Traditional | Sybron Dental Specialties, Inc. | 02/25/1999SE |
| K973439 | Endo Analyzer, Model 8005EAT · Traditional | Sybron Dental Specialties, Inc. | 12/08/1997SE |
| K970715 | System B Heat SourceEAT · Traditional | Sybron Dental Specialties, Inc. | 04/07/1997SE |
| K963862 | Touch N' HeatEAT · Traditional | Sybron Dental Specialties, Inc. | 12/02/1996SE |
| K960799 | Ortho-IceEAT · Traditional | Ultimate Wireforms, Inc. | 05/09/1996SE |
| K950237 | DigitestEAT · Traditional | Parkell, Inc. | 06/09/1995SE |
More from Parkell, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K921604 | Touch N' Heat, ModificationEKZ · Traditional | 08/24/1992SE |
| K915243 | Touch 'N Heat Model 5002, ModificationEKM · Traditional | 01/21/1992SE |
| K890735 | Coated Apex ProbeLQY · Traditional | 04/19/1989SE |
| K864500 | Analytic Technology Endo Analyzer Model 8001LQY · Traditional | 03/19/1987SE |
| K832179 | Hot Probe Model 6001EEG · Traditional | 10/04/1983SE |
| K823486 | Touch-N-Heat Model 5001EKM · Traditional | 01/18/1983SE |
| K820598 | Hot & Cold Pulp Tester #4001EAT · Traditional | 03/19/1982SE |
| K801974 | Analytic Tech. Metal Point Heater #3001ELA · Traditional | 11/12/1980SE |
Questions and answers
When was Pulptester Model 2001 cleared by the FDA?
Pulptester Model 2001 (K790799) received a 510(k) decision of Substantially Equivalent on May 31, 1979, 37 days after the submission was received.
What is the product code of K790799?
The FDA product code is EAT – Tester, Pulp, a Class II (moderate risk) device regulated under 21 CFR 872.1720.