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 |
|---|---|---|---|
| D2486054630 | Spandex Advanced Junior/Small (Black) | HAGER WORLDWIDE, INC. | 2026-06-07 |
| D2486054640 | Spandex Advanced Standard/Med (Pink) | HAGER WORLDWIDE, INC. | 2026-06-07 |
| D2486054651 | Spandex Advanced - 3 Size Combo Kit- Black (1 Junior/Sm, 1 Standard/Med, 1 Large | HAGER WORLDWIDE, INC. | 2026-06-07 |
| D2486054661 | Spandex Advanced - 3 Size Combo Kit- Pink (1 Junior/Sm, 1 Standard/Med, 1 Large) | HAGER WORLDWIDE, INC. | 2026-06-07 |
| 00840456223109 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 00840456223116 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 00840456223123 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 00840456223093 | JMU | JMU DENTAL, INC | 2026-06-05 |
| 07630716603689 | Geistlich Panorama | DSSM AG | 2025-09-17 |
| 07630716603672 | Geistlich Panorama | DSSM AG | 2025-09-17 |
| 07630716603665 | Geistlich Panorama | DSSM AG | 2025-09-17 |
| 07630716603658 | 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 |
| 07615208474183 | GBT Visigate | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-09-25 |
| 07615208474176 | GBT Visigate | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-09-25 |
| 07615208474169 | GBT Visigate | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-09-25 |
| 07615208474152 | GBT Visigate | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-09-25 |
| 07615208473940 | GBT Visigate | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-09-25 |
| 08800000946849 | Osteotome Mallet | Osstem Implant Co., Ltd. | 2022-12-08 |
| 08800209371626 | Mallet | Osstem Implant Co., Ltd. | 2022-12-08 |
| 08800000946856 | Mallet | Osstem Implant Co., Ltd. | 2022-12-08 |
| 08800000945392 | Periosteal Elevator | Osstem Implant Co., Ltd. | 2022-12-08 |
| 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 |