Product code EKD
- Device name
- Instrument, Cutting, Operative
- 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#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00348783008333 | Premier Cavity Prep | PREMIER DENTAL PRODUCTS COMPANY | 2026-04-02 |
| 00348783008340 | Premier Cavity Prep | PREMIER DENTAL PRODUCTS COMPANY | 2026-04-02 |
| 00348783008357 | Premier Cavity Prep | PREMIER DENTAL PRODUCTS COMPANY | 2026-04-02 |
| 00348783012248 | Premier Cavity Prep | PREMIER DENTAL PRODUCTS COMPANY | 2026-04-02 |
| 00348783008265 | Premier Cavity Prep | PREMIER DENTAL PRODUCTS COMPANY | 2026-04-01 |
| 00348783008272 | Premier Cavity Prep | PREMIER DENTAL PRODUCTS COMPANY | 2026-04-01 |
| 00348783008289 | Premier Cavity Prep | PREMIER DENTAL PRODUCTS COMPANY | 2026-04-01 |
| 00348783008319 | Premier Cavity Prep | PREMIER DENTAL PRODUCTS COMPANY | 2026-04-01 |
| 00840018633742 | NORDENT MANUFACTURING | NORDENT MANUFACTURING INC | 2020-05-28 |
| 00840018633667 | NORDENT MANUFACTURING INC | NORDENT MANUFACTURING INC | 2020-05-28 |
| 00840018633674 | NORDENT MANUFACTURING INC | NORDENT MANUFACTURING INC | 2020-05-28 |
| 00840018633681 | NORDENT MANUFACTURING INC | NORDENT MANUFACTURING INC | 2020-05-28 |
| 00840018633698 | NORDENT MANUFACTURING INC | NORDENT MANUFACTURING INC | 2020-05-28 |
| 00840018633704 | NORDENT MANUFACTURING INC | NORDENT MANUFACTURING INC | 2020-05-28 |
| 00840018633711 | NORDENT MANUFACTURING INC | NORDENT MANUFACTURING INC | 2020-05-28 |
| 00840018633728 | NORDENT MANUFACTURING INC | NORDENT MANUFACTURING INC | 2020-05-28 |
| 00840018633735 | NORDENT MANUFACTURING INC | NORDENT MANUFACTURING INC | 2020-05-28 |
| 00840018604056 | BURKHART DENTAL | NORDENT MANUFACTURING INC | 2020-05-21 |
| 00840018604100 | BURKHART DENTAL | NORDENT MANUFACTURING INC | 2020-05-21 |
| 00840018604094 | BURKHART DENTAL | NORDENT MANUFACTURING INC | 2020-05-21 |
| 00840018604087 | BURKHART DENTAL | NORDENT MANUFACTURING INC | 2020-05-21 |
| 00840018604070 | BURKHART DENTAL | NORDENT MANUFACTURING INC | 2020-05-21 |
| 00840018604063 | BURKHART DENTAL | NORDENT MANUFACTURING INC | 2020-05-21 |
| 00840018604049 | BURKHART DENTAL | NORDENT MANUFACTURING INC | 2020-05-21 |
| 00840018604032 | BURKHART DENTAL | NORDENT MANUFACTURING INC | 2020-05-21 |
| 00840018604025 | BURKHART DENTAL | NORDENT MANUFACTURING INC | 2020-05-21 |
| 00840018604018 | BURKHART DENTAL | NORDENT MANUFACTURING INC | 2020-05-21 |
| 00840018604001 | BURKHART DENTAL | NORDENT MANUFACTURING INC | 2020-05-21 |
| 08033707071594 | LEONE SPA | LEONE SPA | 2016-09-25 |
| 08033707071600 | LEONE SPA | LEONE SPA | 2016-09-25 |