High Speed Non-Fiber Optic Swivel Handpiece
FDA 510(k) K902402 · Dentalez Group
510(k) numberK902402
Submission
- Device name
- High Speed Non-Fiber Optic Swivel Handpiece
- Applicant
- Dentalez Group
Lancaster, PA, US - Received
- May 31, 1990
- Decision date
- August 29, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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|---|---|---|---|
| K262202 | Cerasmart ForteEBF · Traditional | GC America, Inc. | 09/10/2026SE |
| K261695 | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)EBF · Traditional | Guilin Kevin Peter Technology Co., Ltd. | 08/31/2026SE |
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| K261485 | Tetric plus Fill;Tetric plus FlowEBF · Traditional | Ivoclar Vivadent, Inc. | 07/01/2026SE |
| K261246 | SRGC-06EBF · Traditional | GC America, Inc. | 06/18/2026SE |
| K261093 | DiafilEBF · Traditional | DiaDent Group International | 06/02/2026SE |
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW…EBF · Traditional | DiaDent Group International | 05/19/2026SE |
| K260805 | Dual CoreEBF · Traditional | Vericom Co., Ltd. | 05/11/2026SE |
| K261357 | Grandio disc multicolorEBF · Traditional | Voco GmbH | 04/27/2026SE |
| K261356 | Dura-CrownEBF · Special | Hangzhou SHINING3D Dental Technology Co., Ltd. | 04/27/2026SE |
More from Hangzhou SHINING3D Dental Technology Co., Ltd.
| 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 |
| K982593 | Lube Free Autochuck Turbine with Vortex Air Seal for Use with Star Dental 430 Series…EFB · Traditional | 10/22/1998SE |
| 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 |
Questions and answers
When was High Speed Non-Fiber Optic Swivel Handpiece cleared by the FDA?
High Speed Non-Fiber Optic Swivel Handpiece (K902402) received a 510(k) decision of Substantially Equivalent on August 29, 1990, 90 days after the submission was received.
What is the product code of K902402?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.