TENEO Dental Treatment Unit and Accessories
FDA 510(k) K151045 · Sirona Dental Systems GmbH
510(k) numberK151045
Submission
- Device name
- TENEO Dental Treatment Unit and Accessories
- Applicant
- Sirona Dental Systems GmbH
Bensheim, DE - Received
- April 20, 2015
- Decision date
- July 24, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K240754 | N2EIA · Special | Megagen Implant Co., Ltd. | 03/21/2024SE |
More from Megagen Implant Co., Ltd.
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| K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SprayEGS · Traditional | 07/02/2015SE |
| K150217 | Orthophos SLOAS · Traditional | 05/08/2015SE |
| K131319 | T1/T2/T3 Turbine FamilyEFB · Traditional | 05/30/2014SE |
| K132773 | Sidexis 4LLZ · Traditional | 12/11/2013SE |
| 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 TENEO Dental Treatment Unit and Accessories cleared by the FDA?
TENEO Dental Treatment Unit and Accessories (K151045) received a 510(k) decision of Substantially Equivalent on July 24, 2015, 95 days after the submission was received.
What is the product code of K151045?
The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.