Product code EKH
- Device name
- Carver, Dental Amalgam, 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 |
|---|---|---|---|
| D955CARWOOD11 | Paul Banditt | Terlain Enterprises, Inc. | 2026-09-25 |
| G8791024570 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-22 |
| G879102455H0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-22 |
| G8791024540 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-22 |
| G879102453H0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-22 |
| G8791024520 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-22 |
| G8791024510 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-22 |
| G149TBSB4280 | TBS BASICS | ACME ENTERPRISE. | 2026-05-20 |
| G149TBSB4130 | TBS BASICS | ACME ENTERPRISE. | 2026-05-20 |
| G149TBSB4120 | TBS BASICS | ACME ENTERPRISE. | 2026-05-20 |
| G149TBSB4110 | TBS BASICS | ACME ENTERPRISE. | 2026-05-20 |
| G149TBSB4100 | TBS BASICS | ACME ENTERPRISE. | 2026-05-20 |
| G149TBSB4090 | TBS BASICS | ACME ENTERPRISE. | 2026-05-20 |
| ESAM2460001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| 00888118121424 | CARVER | KLS-Martin L.P. | 2019-04-15 |
| 00888118069481 | AMALGAM INSTRUMENT | KLS-Martin L.P. | 2018-09-26 |
| 00888118103604 | CARVER | KLS-Martin L.P. | 2018-09-26 |
| 00888118098467 | CARVER | KLS-Martin L.P. | 2018-09-26 |
| 00888118070067 | CARVER | KLS-Martin L.P. | 2018-09-26 |
| 00888118070050 | CARVER | KLS-Martin L.P. | 2018-09-26 |
| 00888118070043 | CARVER | KLS-Martin L.P. | 2018-09-26 |
| 00888118070036 | CARVER | KLS-Martin L.P. | 2018-09-26 |
| 00888118070029 | CARVER | KLS-Martin L.P. | 2018-09-26 |
| 00888118070012 | CARVER | KLS-Martin L.P. | 2018-09-26 |
| 00888118069511 | AMALGAM INSTRUMENT | KLS-Martin L.P. | 2018-09-26 |
| 00888118069504 | AMALGAM INSTRUMENT | KLS-Martin L.P. | 2018-09-26 |
| 00888118069498 | AMALGAM INSTRUMENT | KLS-Martin L.P. | 2018-09-26 |
| 00888118069474 | AMALGAM INSTRUMENT | KLS-Martin L.P. | 2018-09-26 |
| 10381780382348 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-19 |
| 10381780382454 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-19 |