Tooth Slooth
FDA 510(k) K833338 · Joel Lander D.D.S.
510(k) numberK833338
Submission
- Device name
- Tooth Slooth
- Applicant
- Joel Lander D.D.S.
Walker, MI, US - Received
- September 27, 1983
- Decision date
- November 25, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EJB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140144 | Benda WedgeEJB · Traditional | Centrix, Inc. | 07/08/2014SE |
| K023367 | Detectar, Model N123-MIEJB · Traditional | Neks Technologies | 06/25/2003SE |
| K981234 | Flare,File, FillEJB · Traditional | Lone Star Technologies | 06/05/1998SE |
| K930094 | AukusleeveEJB · Traditional | Aukland Medical Plastics, Inc. | 10/20/1993SE |
| K922633 | Cavi-ZymeEJB · Traditional | E&D Dental Products, Inc. | 08/06/1992SE |
| K871818 | Spatula, Dental, CementEJB · Traditional | Military Engineering, Inc. | 07/02/1987SE |
| K823913 | Soft Grip Uni-HandleEJB · Traditional | Treace Medical, Inc. | 01/26/1983SE |
Questions and answers
When was Tooth Slooth cleared by the FDA?
Tooth Slooth (K833338) received a 510(k) decision of Substantially Equivalent on November 25, 1983, 59 days after the submission was received.
What is the product code of K833338?
The FDA product code is EJB – Handle, Instrument, Dental, a Class I (low risk) device regulated under 21 CFR 872.4565.