T1/T2/T3 Turbine Family
FDA 510(k) K131319 · Sirona Dental Systems GmbH
510(k) numberK131319
Submission
- Device name
- T1/T2/T3 Turbine Family
- Applicant
- Sirona Dental Systems GmbH
Bensheim, DE - Received
- May 7, 2013
- Decision date
- May 30, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K160099 | CEREC SpeedGlazeEIH · Traditional | 06/02/2016SE |
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| K123664 | Incoris ZiEIH · Traditional | 04/08/2013SE |
| K123952 | Cerec Blocs C inEIH · Traditional | 03/20/2013SE |
| K123070 | Galileos FamilyOAS · Traditional | 03/15/2013SE |
| K123545 | Incoris TziEIH · Traditional | 02/01/2013SE |
Questions and answers
When was T1/T2/T3 Turbine Family cleared by the FDA?
T1/T2/T3 Turbine Family (K131319) received a 510(k) decision of Substantially Equivalent on May 30, 2014, 388 days after the submission was received.
What is the product code of K131319?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.