Tek-Lube
FDA 510(k) K925080 · Clinical Technology Corp.
510(k) numberK925080
Submission
- Device name
- Tek-Lube
- Applicant
- Clinical Technology Corp.
Scottsdale, AZ, US - Received
- October 7, 1992
- Decision date
- January 31, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K872867 | BiosignFRC · Traditional | 07/06/1988SE |
| K880166 | Bovie Ultrasonic Surgical Aspirator, Model ME2000LFL · Traditional | 02/18/1988SE |
| K872705 | Bovie 400-CT Electrosurgical Generator (Unit)GEI · Traditional | 09/01/1987SE |
| K855138 | Bovie Ultrasonic Surgical SystemLBK · Traditional | 11/10/1986SE |
| K854231 | Electrosurgical Cutting & Coagulation Device/AccesGEI · Traditional | 05/02/1986SE |
| K853507 | Steri-Grip · Traditional | 09/05/1985SE |
| K852986 | Glyco-Sep/Alc Test Kit for Separat of HemoglobinLCP · Traditional | 08/19/1985SE |
| K844565 | Bovie X-10 Electrosurgical Generator(Unit)GEI · Traditional | 02/21/1985SE |
| K841272 | Sickle-Stat Hemoglobin S Screen KitGHM · Traditional | 04/13/1984SE |
| K823077 | Urinary Bladder Temp. Sensor #81-003FLL · Traditional | 03/09/1983SE |
Questions and answers
When was Tek-Lube cleared by the FDA?
Tek-Lube (K925080) received a 510(k) decision of Substantially Equivalent on January 31, 1994, 481 days after the submission was received.
What is the product code of K925080?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.