Soft Grip Uni-Handle
FDA 510(k) K823913 · Treace Medical, Inc.
510(k) numberK823913
Submission
- Device name
- Soft Grip Uni-Handle
- Applicant
- Treace Medical, Inc.
Mchenry, IL, US - Received
- December 28, 1982
- Decision date
- January 26, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K140144 | Benda WedgeEJB · Traditional | Centrix, Inc. | 07/08/2014SE |
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| 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 |
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| K870759 | Cleaning Solution, Catalog No. 8203LRJ · Traditional | 05/07/1987SE |
| K870766 | Prosthesis WireETB · Traditional | 04/15/1987SE |
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Questions and answers
When was Soft Grip Uni-Handle cleared by the FDA?
Soft Grip Uni-Handle (K823913) received a 510(k) decision of Substantially Equivalent on January 26, 1983, 29 days after the submission was received.
What is the product code of K823913?
The FDA product code is EJB – Handle, Instrument, Dental, a Class I (low risk) device regulated under 21 CFR 872.4565.