Suni Max
FDA 510(k) K000049 · Satelec
510(k) numberK000049
Submission
- Device name
- Suni Max
- Applicant
- Satelec
Wellesley, MA, US - Received
- January 7, 2000
- Decision date
- April 4, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EFB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251389 | High speed air turbine handpieceEFB · Traditional | Foshan Topmed Dental Co., Ltd. | 01/12/2026SE |
| 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 |
| K240337 | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)EFB · Traditional | Guangdong Jinme Medical Technology Co., Ltd. | 11/13/2024SE |
| K241074 | High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low…EFB · Traditional | Foshan Soco Precision Instrument Co., Ltd. | 11/12/2024SE |
| K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System…EFB · Traditional | Nakanishi, Inc. | 09/20/2024SE |
| 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 |
| K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)EFB · Traditional | Nakanishi, Inc. | 04/25/2024SE |
| K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsEFB · Traditional | Foshan Coxo Medical Instrument Co., Ltd. | 09/22/2023SE |
| K232243 | EVO 700 series high speed handpieceEFB · Special | Ttbio Corp. | 08/23/2023SE |
More from Ttbio Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K110379 | Air-N-GoEFB · Traditional | 12/08/2011SE |
| K100410 | Piezoelectric SystemJDX · Traditional | 04/28/2010SE |
| K091331 | Piezotome 2DZI · Traditional | 12/11/2009SE |
| K091252 | Implant Center 2DZI · Traditional | 07/22/2009SE |
| K082116 | Hemostasyl PasteMVL · Traditional | 12/17/2008SE |
| K072181 | Mini LED AutofocusEBZ · Traditional | 09/19/2007SE |
| K071965 | I-SurgeEFB · Traditional | 09/10/2007SE |
| K060275 | PiezotomeELC · Traditional | 05/03/2006SE |
| K060274 | PiezotomeDZI · Traditional | 05/01/2006SE |
| K053328 | Biosplint Splinting RibbonEBI · Traditional | 01/25/2006SE |
Questions and answers
When was Suni Max cleared by the FDA?
Suni Max (K000049) received a 510(k) decision of Substantially Equivalent on April 4, 2000, 88 days after the submission was received.
What is the product code of K000049?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.