Product code EJB
- Device name
- Handle, Instrument, Dental
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4565
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K140144 | BENDA WEDGE | Centrix, Inc. | 2014-07-08 |
| K023367 | DETECTAR, MODEL N123-MI | Neks Technologies | 2003-06-25 |
| K981234 | FLARE,FILE, FILL | Lone Star Technologies | 1998-06-05 |
| K930094 | AUKUSLEEVE | Aukland Medical Plastics, Inc. | 1993-10-20 |
| K922633 | CAVI-ZYME | E&D Dental Products, Inc. | 1992-08-06 |
| K871818 | SPATULA, DENTAL, CEMENT | Military Engineering, Inc. | 1987-07-02 |
| K833338 | TOOTH SLOOTH | Joel Lander D.D.S. | 1983-11-25 |
| K823913 | SOFT GRIP UNI-HANDLE | Treace Medical, Inc. | 1983-01-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| ESAM13322071 | STOMA® | Storz am Mark GmbH | 2023-06-13 |
| EMICES61 | Ena Shiny | MICERIUM SPA | 2023-05-05 |
| EMICTPENMP1 | Enamel Plus Stain & Instruments | MICERIUM SPA | 2023-05-05 |
| EMICTRAG1 | Enamel Plus Stain & Instruments | MICERIUM SPA | 2023-05-05 |
| EMICTRAW1 | Enamel Plus Stain & Instruments | MICERIUM SPA | 2023-05-05 |
| EMICCHFF251 | Enamel Plus Hri FLOW | MICERIUM SPA | 2023-05-05 |
| EMICCOSM3T1 | Ena ® | MICERIUM SPA | 2021-12-09 |
| ESAM15108001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5110201 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM15108101 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM15109101 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM15112251 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4520031 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5104001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5107001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5109001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5110001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5110101 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM14520031 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM14516031 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM14515031 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM14514031 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM14512001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM14510001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13389001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13339001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13338001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13325001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13322021 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13322011 | STOMA® | Storz am Mark GmbH | 2020-08-27 |