Product code EIF
- Device name
- Accessories, Retractor, Dental
- 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 |
|---|---|---|---|
| 07630716603658 | Geistlich Panorama | DSSM AG | 2025-09-17 |
| 07630716603665 | Geistlich Panorama | DSSM AG | 2025-09-17 |
| 07630716603672 | Geistlich Panorama | DSSM AG | 2025-09-17 |
| 07630716603689 | Geistlich Panorama | DSSM AG | 2025-09-17 |
| 07615208516982 | OptraGate 2 | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2025-02-21 |
| 07615208513660 | OptraGate 2 | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2024-11-19 |
| 07615208484076 | OptraGate | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2024-09-11 |
| 07615208474152 | GBT Visigate | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-09-25 |
| 07615208474169 | GBT Visigate | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-09-25 |
| 07615208474176 | GBT Visigate | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-09-25 |
| 07615208474183 | GBT Visigate | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-09-25 |
| 07615208473940 | GBT Visigate | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-09-25 |
| 00014081054500 | Mirahold Adult | HAGER WORLDWIDE, INC. | 2023-07-13 |
| 00014081052124 | Lip-Ex | HAGER WORLDWIDE, INC. | 2023-07-13 |
| 08800209371626 | Mallet | Osstem Implant Co., Ltd. | 2022-12-08 |
| 08800000946856 | Mallet | Osstem Implant Co., Ltd. | 2022-12-08 |
| 08800000946849 | Osteotome Mallet | Osstem Implant Co., Ltd. | 2022-12-08 |
| 08800000945392 | Periosteal Elevator | Osstem Implant Co., Ltd. | 2022-12-08 |
| 14260576943481 | CEKA & PRECI-LINE ATTACHMENTS | Alphadent NV | 2021-04-20 |
| 14260576943498 | CEKA & PRECI-LINE ATTACHMENTS | Alphadent NV | 2021-04-20 |
| 14260576944013 | CEKA & PRECI-LINE ATTACHMENTS | Alphadent NV | 2021-03-30 |
| 00075020044129 | Philips Zoom | Discus Dental, LLC | 2020-08-28 |
| H65810238960 | Henry Schein | HENRY SCHEIN, INC. | 2020-05-22 |
| H65810255250 | Henry Schein | HENRY SCHEIN, INC. | 2020-05-22 |
| H65810263030 | Henry Schein | HENRY SCHEIN, INC. | 2020-05-22 |
| H65810266570 | Henry Schein | HENRY SCHEIN, INC. | 2020-05-22 |
| H65890012510 | Henry Schein | HENRY SCHEIN, INC. | 2020-05-22 |
| H65890012520 | Henry Schein | HENRY SCHEIN, INC. | 2020-05-22 |
| 00304040039366 | Henry Schein | HENRY SCHEIN, INC. | 2017-03-30 |
| 00304040039373 | Henry Schein | HENRY SCHEIN, INC. | 2017-03-30 |