MD 10, Sem, SM 12, CBM
FDA 510(k) K000710 · Nouvag AG
510(k) numberK000710
Submission
- Device name
- MD 10, Sem, SM 12, CBM
- Applicant
- Nouvag AG
Kaufbeuren, DE - Received
- March 2, 2000
- Decision date
- May 11, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K251388 | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…EFB · Traditional | Foshan Topmed Dental Co., Ltd. | 01/12/2026SE |
| K242179 | Synea Fusion Handpieces (Intensiv & Profin)EFB · Traditional | W&H Dentalwerk Bürmoos GmbH | 02/28/2025SE |
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| K241074 | High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low…EFB · Traditional | Foshan Soco Precision Instrument Co., Ltd. | 11/12/2024SE |
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| K233122 | High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800…EFB · Traditional | Litu Tech , Ltd. | 04/30/2024SE |
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| K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsEFB · Traditional | Foshan Coxo Medical Instrument Co., Ltd. | 09/22/2023SE |
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| K081191 | TCM Endo 20EKX · Traditional | 08/07/2008SE |
| K071588 | Dispenser DP 20FRN · Traditional | 11/26/2007SE |
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| 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 |
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| K981679 | TCM 3000 and TCM EndoEFB · Traditional | 02/09/1999SE |
Questions and answers
When was MD 10, Sem, SM 12, CBM cleared by the FDA?
MD 10, Sem, SM 12, CBM (K000710) received a 510(k) decision of Substantially Equivalent on May 11, 2000, 70 days after the submission was received.
What is the product code of K000710?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.