E-Type Speed Increaser Contra Angle, External Irrigation, Internal Irrigation
FDA 510(k) K972569 · Nsk Nakanishi, Inc.
510(k) numberK972569
Submission
- Device name
- E-Type Speed Increaser Contra Angle, External Irrigation, Internal Irrigation
- Applicant
- Nsk Nakanishi, Inc.
Tochigi-Ken, JP - Received
- July 10, 1997
- Decision date
- October 8, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 510(k) | Device | Decision |
|---|---|---|
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| K991021 | Sonic Scaler with Fiber Optic, Model Nas-L, Sonic Scaler Without Fiber Optic, Model Nas-NlELC · Traditional | 06/23/1999SE |
| K990954 | Elec-Mate, Models EX-6 Set, EX-6L Set, EX-30 SetEBW · Traditional | 06/09/1999SE |
| K990682 | Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max), Endo-Mate (600RPM Max.)EKX · Traditional | 03/24/1999SE |
| K990646 | Portable Electric Motor-Handpiece Unit, Handy-MateEKX · Traditional | 03/19/1999SE |
| K980162 | Mach-Sigma Handpiece, UltrapushEFB · Traditional | 06/05/1998SE |
| K972924 | Surgic II Implant Control UnitEBW · Traditional | 10/30/1997SE |
| K971774 | NSK Push-Button Midwest Replacement Turbine:For Quietair and TraditionEFB · Traditional | 06/20/1997SE |
| K970953 | E-Type Speed Reducer Contra AngleKMW · Traditional | 04/15/1997SE |
| K962542 | Air Motor Handpiece TN-102EFB · Traditional | 09/24/1996SE |
Questions and answers
When was E-Type Speed Increaser Contra Angle, External Irrigation, Internal Irrigation cleared by the FDA?
E-Type Speed Increaser Contra Angle, External Irrigation, Internal Irrigation (K972569) received a 510(k) decision of Substantially Equivalent on October 8, 1997, 90 days after the submission was received.
What is the product code of K972569?
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.