Lubrina 2
FDA 510(k) K190509 · J. Morita USA, Inc.
510(k) numberK190509
Submission
- Device name
- Lubrina 2
- Applicant
- J. Morita USA, Inc.
Irvine, CA, US - Received
- March 1, 2019
- Decision date
- March 4, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsEFB · Traditional | Foshan Coxo Medical Instrument Co., Ltd. | 09/22/2023SE |
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| K170275 | Tri Auto ZX2EKX · Traditional | 09/11/2017SE |
| K120377 | Adverl Evo Er: Yag Laser for Dentistry MEY-1-AGEX · Traditional | 07/25/2012SE |
| K112665 | Tri Auto Mini - Endodeontic Treatment Motorized HandpieceEKX · Traditional | 05/04/2012SE |
| K103697 | TorqtechEGS · Traditional | 01/20/2012SE |
| K090925 | Multiple (Apex Locator), Model RCM-7LQY · Traditional | 11/23/2009SE |
| K091065 | Air Torx, Model TRA-200, TRA-200-CP3, TRA-200-CP4EFB · Traditional | 10/16/2009SE |
Questions and answers
When was Lubrina 2 cleared by the FDA?
Lubrina 2 (K190509) received a 510(k) decision of Substantially Equivalent on March 4, 2020, 369 days after the submission was received.
What is the product code of K190509?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.