Product code EKW
- Device name
- Broach, Endodontic
- 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 |
|---|---|---|---|
| K871493 | DENTI-TRAY(TM) | Advanced Medical, Inc. | 1987-06-24 |
| K870765 | CANNULATED INSTRUMENT CLEANERS | Treace Medical, Inc. | 1987-05-27 |
| K862523 | MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS | Walter Lorenz Surgical, Inc. | 1986-08-01 |
| K831749 | ENDODONTIC BROACH(76EKN) BARBED BROACH | Union Branch | 1983-07-12 |
| K823489 | ENDODONTIC BROACH-BARBED BROACH | Union Broach, Div. Moyco Industries, Inc. | 1982-12-15 |
| K800292 | ENDEX BROACH, ENDODONTIC | Ipco Corp. | 1980-02-19 |
| K760985 | HAND INSTRUMENTS | Adp Intl., Inc. | 1976-11-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07630049992146 | Barbed broaches 31mm 040, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049992177 | Barbed broaches 31mm 060, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049997370 | Barbed broaches 31mm 025, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049997387 | Barbed broaches 31mm 030, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049997394 | Barbed broaches 31mm 050, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049992122 | Barbed broaches 31mm 035, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| H65810035680 | Henry Schein | HENRY SCHEIN, INC. | 2020-09-11 |
| H65810042590 | Henry Schein | HENRY SCHEIN, INC. | 2020-08-25 |
| H65810042560 | Henry Schein | HENRY SCHEIN, INC. | 2020-08-25 |
| H65810039170 | Henry Schein | HENRY SCHEIN, INC. | 2020-08-25 |
| H65810035770 | Henry Schein | HENRY SCHEIN, INC. | 2020-08-25 |
| H65810024870 | Henry Schein | HENRY SCHEIN, INC. | 2020-08-25 |
| H65810020890 | Henry Schein | HENRY SCHEIN, INC. | 2020-08-25 |
| H65810014030 | Henry Schein | HENRY SCHEIN, INC. | 2020-08-25 |
| H65810012290 | Henry Schein | HENRY SCHEIN, INC. | 2020-08-25 |
| 08806383520539 | BARBED BROACHES | DiaDent Group International | 2020-06-18 |
| 08806383520546 | BARBED BROACHES | DiaDent Group International | 2020-06-18 |
| 08806383520553 | BARBED BROACHES | DiaDent Group International | 2020-06-18 |
| 08806383520560 | BARBED BROACHES | DiaDent Group International | 2020-06-18 |
| 08806383520577 | BARBED BROACHES | DiaDent Group International | 2020-06-18 |
| 08806383520584 | BARBED BROACHES | DiaDent Group International | 2020-06-18 |
| 08806383520522 | BARBED BROACHES | DiaDent Group International | 2020-06-18 |
| 08806383520515 | BARBED BROACHES | DiaDent Group International | 2020-06-18 |
| 08806383520508 | BARBED BROACHES | DiaDent Group International | 2020-06-18 |
| 08806383520492 | BARBED BROACHES | DiaDent Group International | 2020-06-18 |
| 08806383520485 | BARBED BROACHES | DiaDent Group International | 2020-06-18 |
| 08806383520478 | BARBED BROACHES | DiaDent Group International | 2020-06-18 |
| 08806383520461 | BARBED BROACHES | DiaDent Group International | 2020-06-18 |
| 08806383520454 | BARBED BROACHES | DiaDent Group International | 2020-06-18 |
| 08806383520447 | BARBED BROACHES | DiaDent Group International | 2020-06-18 |