Product code ELK
- Device name
- Teeth, Artificial, Backing And Facing
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.3910
- 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 |
|---|---|---|---|
| 07506338322416 | ISOTEK, MDC Dental | MDC DENTAL | 2025-04-29 |
| 07506338322423 | ISOTEK, MDC Dental | MDC DENTAL | 2025-04-29 |
| 17506338322413 | ISOTEK, MDC Dental | MDC DENTAL | 2025-04-29 |
| 17506338322420 | ISOTEK, MDC Dental | MDC DENTAL | 2025-04-29 |
| 08720604633795 | Vertex-Dental BV | Vertex-Dental B.V. | 2024-04-19 |
| 08720604633788 | Vertex-Dental BV | Vertex-Dental B.V. | 2024-04-19 |
| 08720604633801 | Vertex-Dental BV | Vertex-Dental B.V. | 2024-04-19 |
| 08720604633825 | Vertex-Dental BV | Vertex-Dental B.V. | 2024-04-19 |
| 08720604633818 | Vertex-Dental BV | Vertex-Dental B.V. | 2024-04-19 |
| 08720604633771 | Vertex-Dental BV | Vertex-Dental B.V. | 2024-04-19 |
| 08719425508962 | Vertex-Dental BV | Vertex-Dental B.V. | 2023-08-03 |
| 08719425508955 | Vertex-Dental BV | Vertex-Dental B.V. | 2023-08-03 |
| 08719425508948 | Vertex-Dental BV | Vertex-Dental B.V. | 2023-08-03 |
| 08719425508924 | Vertex-Dental BV | Vertex-Dental B.V. | 2023-08-03 |
| 08719425508979 | Vertex-Dental BV | Vertex-Dental B.V. | 2023-08-03 |
| 08719425508986 | Vertex-Dental BV | Vertex-Dental B.V. | 2023-08-03 |
| 00850039704178 | OnX Tough - Hollywood Bleach | Sprintray, Inc. | 2022-10-04 |
| 07506338314855 | Newtek, MDC Dental | MDC DENTAL | 2022-09-28 |
| 07506338314848 | Newtek, MDC Dental | MDC DENTAL | 2022-09-28 |
| 17506338314845 | Newtek, MDC Dental | MDC DENTAL | 2022-09-28 |
| 17506338314852 | Newtek, MDC Dental | MDC DENTAL | 2022-09-28 |
| 00850039704093 | OnX - B1 | Sprintray, Inc. | 2022-02-28 |
| 00850039704086 | OnX - A1 | Sprintray, Inc. | 2022-02-28 |
| 00850039704079 | OnX - Bleach | Sprintray, Inc. | 2022-02-28 |
| 08719425508702 | Ceramill | Vertex-Dental B.V. | 2019-02-06 |
| 08719425508672 | Ceramill | Vertex-Dental B.V. | 2019-02-06 |
| 08719425508696 | Ceramill | Vertex-Dental B.V. | 2019-02-06 |
| 08719425508733 | Ceramill | Vertex-Dental B.V. | 2019-02-05 |
| 08719425508719 | Ceramill | Vertex-Dental B.V. | 2019-02-05 |
| 08719425508689 | Ceramill | Vertex-Dental B.V. | 2019-02-05 |