Touch N' Heat
FDA 510(k) K963862 · Sybron Dental Specialties, Inc.
510(k) numberK963862
Submission
- Device name
- Touch N' Heat
- Applicant
- Sybron Dental Specialties, Inc.
Orange, CA, US - Received
- September 24, 1996
- Decision date
- December 2, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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 |
| K960799 | Ortho-IceEAT · Traditional | Ultimate Wireforms, Inc. | 05/09/1996SE |
| K950237 | DigitestEAT · Traditional | Parkell, Inc. | 06/09/1995SE |
| K950238 | Gental PulseEAT · Traditional | Parkell, Inc. | 05/09/1995SE |
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| 510(k) | Device | Decision |
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| K160097 | Image Fast Set, Image Regular SetELW · Traditional | 08/05/2016SE |
| K153067 | Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressKIF · Traditional | 07/27/2016SE |
| K152956 | Pulp Canal Sealer, Pulp Canal Sealer EWTKIF · Traditional | 05/06/2016SE |
| K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesKIF · Special | 04/14/2016SE |
| K151526 | Zone, ZoneFree, Zone A1EMA · Traditional | 09/10/2015SE |
| K151332 | Nexus Universal, Nexus Universal ChromaEMA · Abbreviated | 08/17/2015SE |
| K150559 | Life Fast Set, Life Regular SetEJK · Special | 06/19/2015SE |
| K143209 | SonicFill 2EBF · Traditional | 02/05/2015SE |
Questions and answers
When was Touch N' Heat cleared by the FDA?
Touch N' Heat (K963862) received a 510(k) decision of Substantially Equivalent on December 2, 1996, 69 days after the submission was received.
What is the product code of K963862?
The FDA product code is EAT – Tester, Pulp, a Class II (moderate risk) device regulated under 21 CFR 872.1720.