Flare,File, Fill
FDA 510(k) K981234 · Lone Star Technologies
510(k) numberK981234
Submission
- Device name
- Flare,File, Fill
- Applicant
- Lone Star Technologies
Chatham, NJ, US - Received
- April 4, 1998
- Decision date
- June 5, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K833338 | Tooth SloothEJB · Traditional | Joel Lander D.D.S. | 11/25/1983SE |
| K823913 | Soft Grip Uni-HandleEJB · Traditional | Treace Medical, Inc. | 01/26/1983SE |
More from Treace Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K980968 | Lone Star Impression SystemsELW · Traditional | 06/09/1998SE |
Questions and answers
When was Flare,File, Fill cleared by the FDA?
Flare,File, Fill (K981234) received a 510(k) decision of Substantially Equivalent on June 5, 1998, 62 days after the submission was received.
What is the product code of K981234?
The FDA product code is EJB – Handle, Instrument, Dental, a Class I (low risk) device regulated under 21 CFR 872.4565.