TCM Endo III
FDA 510(k) K013185 · Nouvag AG
510(k) numberK013185
Submission
- Device name
- TCM Endo III
- Applicant
- Nouvag AG
Orange, CA, US - Received
- September 24, 2001
- Decision date
- November 28, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K101172 | RDT3 Handpiece Head Model RDT3EFA · Traditional | Redent Nova, Ltd. | 07/27/2010SE |
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| K254135 | LipoSurg ARTISTQPB · Traditional | 09/05/2026SE |
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| K081191 | TCM Endo 20EKX · Traditional | 08/07/2008SE |
| K071588 | Dispenser DP 20FRN · Traditional | 11/26/2007SE |
| K042822 | TCM Endo V, Model 1534EKX · Traditional | 12/22/2004SE |
| K042943 | Nouvag AG - Vacuson 40 and Vacuson 60BTA · Traditional | 12/17/2004SE |
| K042434 | Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55DZI · Traditional | 11/03/2004SE |
| K022505 | Contra-Angle, Models 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063…EGS · Traditional | 10/01/2003SE |
| K000710 | MD 10, Sem, SM 12, CBMEFB · Traditional | 05/11/2000SE |
| K981679 | TCM 3000 and TCM EndoEFB · Traditional | 02/09/1999SE |
Questions and answers
When was TCM Endo III cleared by the FDA?
TCM Endo III (K013185) received a 510(k) decision of Substantially Equivalent on November 28, 2001, 65 days after the submission was received.
What is the product code of K013185?
The FDA product code is EFA – Handpiece, Belt And/Or Gear Driven, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.