Product code EJE
- Device name
- Frame, Rubber Dam
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.6300
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- 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 |
|---|---|---|---|
| G149TBSB2100 | TBS BASICS | ACME ENTERPRISE. | 2026-05-16 |
| 00813677023339 | PDT, Inc. | PDT, INC. | 2024-06-27 |
| 00813677024985 | PDT, Inc. | PDT, INC. | 2024-06-27 |
| D2483553190 | Plast Frame | HAGER WORLDWIDE, INC. | 2024-04-16 |
| 08800075603470 | OSUNG MND | OSUNG MND Co., Ltd. | 2024-02-23 |
| 08800075603463 | OSUNG MND | OSUNG MND Co., Ltd. | 2024-02-23 |
| 07506338321761 | Nic Tone, MDC Dental | MDC DENTAL | 2023-11-17 |
| 00014081053190 | Plast Frame | HAGER WORLDWIDE, INC. | 2023-03-27 |
| 07630392900416 | Hysolate | Dent4You AG | 2023-02-28 |
| 07630392900409 | Hysolate | Dent4You AG | 2023-02-28 |
| 07506338300575 | Nic Tone, MDC Dental | MDC DENTAL | 2022-12-17 |
| 07506338300704 | Nic Tone, MDC Dental | MDC DENTAL | 2022-12-17 |
| 07506338300698 | Nic Tone, MDC Dental | MDC DENTAL | 2022-12-17 |
| 07506338300681 | Nic Tone, MDC Dental | MDC DENTAL | 2022-12-17 |
| 07506338300674 | Nic Tone, MDC Dental | MDC DENTAL | 2022-12-17 |
| 07506338300667 | Nic Tone, MDC Dental | MDC DENTAL | 2022-12-17 |
| 07506338300599 | Nic Tone, MDC Dental | MDC DENTAL | 2022-12-08 |
| 07506338300568 | Nic Tone, MDC Dental | MDC DENTAL | 2022-12-08 |
| 00302731777016 | Young | YOUNG DENTAL MANUFACTURING I, LLC | 2022-10-16 |
| 00302731776019 | Young | YOUNG DENTAL MANUFACTURING I, LLC | 2022-10-16 |
| 00302731771014 | Young | YOUNG DENTAL MANUFACTURING I, LLC | 2022-10-16 |
| 00302731770017 | Young | YOUNG DENTAL MANUFACTURING I, LLC | 2022-10-16 |
| 00302731714011 | Young | YOUNG DENTAL MANUFACTURING I, LLC | 2022-10-16 |
| D661H005600 | Hygenic | COLTENE/WHALEDENT INC | 2019-02-27 |
| D661H070830 | Hygenic | COLTENE/WHALEDENT INC | 2019-02-12 |
| D661H070820 | Hygenic | COLTENE/WHALEDENT INC | 2019-02-11 |
| D661H014160 | Hygenic | COLTENE/WHALEDENT INC | 2019-02-11 |
| D661H014140 | Hygenic | COLTENE/WHALEDENT INC | 2019-02-11 |
| D7022055540 | StarDental Instrument Solutions | DENTALEZ, INC. | 2018-11-05 |
| 10381780495932 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-10-24 |