Kavo Quattrocare
FDA 510(k) K012308 · Kavo America
510(k) numberK012308
Submission
- Device name
- Kavo Quattrocare
- Applicant
- Kavo America
Lake Zurich, IL, US - Received
- July 23, 2001
- Decision date
- June 26, 2002
- 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 |
|---|---|---|
| K073074 | Key Laser III 1243 US with DetectGEX · Special | 07/10/2008SE |
| K072262 | Gentleray 980 Diode Laser SystemGEX · Traditional | 10/26/2007SE |
| K063624 | Kavo Everest C-TempEBG · Traditional | 02/08/2007SE |
| K051909 | DiagnodentNBL · Traditional | 10/21/2005SE |
| K030146 | Kavo Key Laser 1242 and Kavo Key Laser 1243+NVK · Traditional | 08/03/2005SE |
| K042394 | Diagnodent Perio Tip (Accessory)NBL · Traditional | 08/02/2005SE |
| K050744 | Kavo Ergocom/ErgocamLLZ · Traditional | 04/21/2005SE |
| K050019 | In Exam Intraoral Dental X-Ray SystemEHD · Traditional | 01/31/2005SE |
| K042872 | Rondoflex Plus 360KOJ · Special | 11/23/2004SE |
| K033221 | Kavo Everest Zh-BlankEIH · Special | 10/28/2003SE |
Questions and answers
When was Kavo Quattrocare cleared by the FDA?
Kavo Quattrocare (K012308) received a 510(k) decision of Substantially Equivalent on June 26, 2002, 338 days after the submission was received.
What is the product code of K012308?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.