Lube Free Autochuck Turbine with Vortex Air Seal for Use with Star Dental 430 Series Lube Free High Speed Dental Handpie
FDA 510(k) K982593 · Dentalez Group
510(k) numberK982593
Submission
- Device name
- Lube Free Autochuck Turbine with Vortex Air Seal for Use with Star Dental 430 Series Lube Free High Speed Dental Handpie
- Applicant
- Dentalez Group
Lancaster, PA, US - Received
- July 24, 1998
- Decision date
- October 22, 1998
- 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 |
|---|---|---|
| K030133 | Solara Series Comprised of the Solara High Speed Dental Handpiece and the Solara Plus…EBF · Traditional | 04/29/2003SE |
| K021378 | Portable HDX Intraoral X-RayEHD · Traditional | 06/07/2002SE |
| K990844 | Stardental Axcs Sterile Water SystemEIA · Traditional | 05/28/1999SE |
| K983574 | Stardental Titan 3 Lubefree Motor AttachmentsEGS · Traditional | 01/08/1999SE |
| K960719 | Star Dental 430 Series High Speed HandpieceEFA · Traditional | 03/28/1996SE |
| K960507 | Star Dental Pushbutton Autochuck Replacement Turbine for Midwest HandpiecesEFA · Traditional | 03/28/1996SE |
| K960260 | Star Titan Series Motors & AttachmentsEFA · Traditional | 03/28/1996SE |
| K925567 | E 4000 Dental Operating ChairKLC · Traditional | 03/10/1994SE |
| K931093 | Quick-Connect 360 Swivel Tip Autoclavable SyringeEIA · Traditional | 01/21/1994SE |
| K902402 | High Speed Non-Fiber Optic Swivel HandpieceEBF · Traditional | 08/29/1990SE |
Questions and answers
When was Lube Free Autochuck Turbine with Vortex Air Seal for Use with Star Dental 430 Series Lube Free High Speed Dental Handpie cleared by the FDA?
Lube Free Autochuck Turbine with Vortex Air Seal for Use with Star Dental 430 Series Lube Free High Speed Dental Handpie (K982593) received a 510(k) decision of Substantially Equivalent on October 22, 1998, 90 days after the submission was received.
What is the product code of K982593?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.