Product code EKP
- Device name
- Reamer, Pulp Canal, 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 |
|---|---|---|---|
| K823686 | REAMER TYPE K ENDODONTIC | United Dental Mfg., Inc. | 1982-12-28 |
| K822620 | ROOT CANAL REAMERS, TYPE K | Union Broach, Div. Moyco Industries, Inc. | 1982-09-28 |
| K800291 | ENDEX REAMERS PULP CANAL, ENDODONTIC | Ipco Corp. | 1980-02-19 |
| K770331 | DIALYSIS, JET SYSTEM | Janneck Ent. of Texas | 1977-04-20 |
| K770598 | ENDODONTIC INSTRUMENTS, R&R CUTWELL | Ransom and Randolph | 1977-04-05 |
| K770367 | ROOT CANAL FILES & REAMERS | Cemco Tool Co., Inc. | 1977-03-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07630049996595 | Reamer 21mm 008, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049996731 | Reamer 25mm 008, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049996724 | Reamer 21mm 080, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049996717 | Reamer 21mm 070, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049996700 | Reamer 21mm 060, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049996694 | Reamer 21mm 055, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049996687 | Reamer 21mm 050, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049996670 | Reamer 21mm 045, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049996663 | Reamer 21mm 040, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049996656 | Reamer 21mm 035, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049996649 | Reamer 21mm 030, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049996632 | Reamer 21mm 025, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049996625 | Reamer 21mm 020, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049996618 | Reamer 21mm 015, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049996601 | Reamer 21mm 010, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049902770 | Reamer 21mm 055, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049990364 | Reamer 29mm 080, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049990340 | Reamer 29mm 070, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049990326 | Reamer 29mm 060, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049990302 | Reamer 29mm 055, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049990289 | Reamer 29mm 050, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049990265 | Reamer 29mm 045, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049990241 | Reamer 29mm 040, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049990227 | Reamer 29mm 035, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049990203 | Reamer 29mm 030, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049990180 | Reamer 29mm 025, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049990166 | Reamer 29mm 020, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049990142 | Reamer 29mm 015, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049990128 | Reamer 29mm 010, pu: 6 pcs | Diaswiss SA | 2023-10-02 |
| 07630049990104 | Reamer 29mm 008, pu: 6 pcs | Diaswiss SA | 2023-10-02 |