TS-301 Three-Way Pulp Tester
FDA 510(k) K800138 · Tamler-Stoneham Instruments
510(k) numberK800138
Submission
- Device name
- TS-301 Three-Way Pulp Tester
- Applicant
- Tamler-Stoneham Instruments
Mchenry, IL, US - Received
- January 21, 1980
- Decision date
- February 13, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EAT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
Questions and answers
When was TS-301 Three-Way Pulp Tester cleared by the FDA?
TS-301 Three-Way Pulp Tester (K800138) received a 510(k) decision of Substantially Equivalent on February 13, 1980, 23 days after the submission was received.
What is the product code of K800138?
The FDA product code is EAT – Tester, Pulp, a Class II (moderate risk) device regulated under 21 CFR 872.1720.