Stardental Titan 3 Lubefree Motor Attachments
FDA 510(k) K983574 · Dentalez Group
510(k) numberK983574
Submission
- Device name
- Stardental Titan 3 Lubefree Motor Attachments
- Applicant
- Dentalez Group
Lancaster, PA, US - Received
- October 13, 1998
- Decision date
- January 8, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EGS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251869 | Disposable Prophy Angle (3399-60, 3399-090, 3399-105)EGS · Traditional | Premium Plus (Dongguan) Limited | 09/15/2025SE |
| K240950 | Disposable Prophy AngleEGS · Abbreviated | Pacific Care Limited | 05/28/2025SE |
| K240183 | Star E900 Handpiece SeriesEGS · Traditional | Dentalez, Inc., Stardental Division | 09/19/2024SE |
| K230106 | General Cutting StraightEGS · Traditional | Nakanishi, Inc. | 05/24/2023SE |
| K222518 | FX ContraEGS · Traditional | Nakanishi, Inc. | 11/17/2022SE |
| K220874 | Smooth Drive contra angle and straight handpiecesEGS · Traditional | Lares Research | 11/07/2022SE |
| K220346 | Lotus Prophy AngleEGS · Traditional | Ajk Engineering, Inc. | 11/07/2022SE |
| K220577 | Dental Handpiece, Model CA160, CA160L, and CA500LEGS · Traditional | Micro-Nx Co., Ltd. | 07/29/2022SE |
| K213139 | SURGmatic S15 L ProEGS · Traditional | Kavo Dental GmbH | 12/21/2021SE |
| K202960 | General Cutting Contra HandpieceEGS · Special | Nakanishi, Inc. | 10/27/2020SE |
More from Nakanishi, Inc.
| 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 |
| 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 |
| K902402 | High Speed Non-Fiber Optic Swivel HandpieceEBF · Traditional | 08/29/1990SE |
Questions and answers
When was Stardental Titan 3 Lubefree Motor Attachments cleared by the FDA?
Stardental Titan 3 Lubefree Motor Attachments (K983574) received a 510(k) decision of Substantially Equivalent on January 8, 1999, 87 days after the submission was received.
What is the product code of K983574?
The FDA product code is EGS – Handpiece, Contra- And Right-Angle Attachment, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.