Product code EBR
- Device name
- Unit, Suction Operatory
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.6640
- 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 |
|---|---|---|---|
| 00841709122286 | Midmark | MIDMARK CORPORATION | 2026-02-20 |
| 06971119541910 | Suction machine | Guangdong JINME Medical Technology Co., Ltd. | 2025-07-15 |
| 00810032660796 | Isolite, i3 | ZYRIS, INC. | 2024-04-19 |
| 00810032660789 | Isolite, i3 | ZYRIS, INC. | 2024-04-19 |
| 00810032660772 | Isolite, i3 | ZYRIS, INC. | 2024-04-19 |
| 00810032660765 | Isolite, i3 | ZYRIS, INC. | 2024-04-19 |
| 00810032660710 | Isolite, i2 | ZYRIS, INC. | 2024-04-19 |
| 00810032660444 | Isolite, i3 | ZYRIS, INC. | 2024-04-08 |
| 00810032660338 | Isovac2 | ZYRIS, INC. | 2024-04-08 |
| 00810032660420 | Isolite Core | ZYRIS, INC. | 2024-04-08 |
| 00810032660437 | Isolite Core+ | ZYRIS, INC. | 2024-04-08 |
| 00810032660482 | Maintenance Kit | ZYRIS, INC. | 2024-04-08 |
| 00810032660505 | Accessories | ZYRIS, INC. | 2024-04-08 |
| 00810032661083 | Isovac | ZYRIS, INC. | 2024-04-08 |
| 08052141312230 | Suction set 2.20 m with terminal cannula Omniasp and autologous bone filterl | OMNIA SRL | 2023-06-23 |
| 08052141312650 | Surgical suction tube 1.85 m with conical fitting | OMNIA SRL | 2023-06-23 |
| 08052141312636 | Sterile Aspiration Tips | OMNIA SRL | 2023-06-23 |
| 08052141312612 | Sterile Aspiration Tips | OMNIA SRL | 2023-06-23 |
| 08052141312353 | Surgical aspirator 2.20 m with cannula Yankauer without aspiration control | OMNIA SRL | 2023-06-23 |
| 08052141311684 | Surgical aspirator 2.20 m with Yankauer suction tip, with aspiration control | OMNIA SRL | 2023-06-23 |
| 10194665005726 | A-dec | A-DEC, INC. | 2022-12-13 |
| 10194665005719 | A-dec | A-DEC, INC. | 2022-12-13 |
| 03615140001991 | HYGITECH | HYGITECH | 2020-12-15 |
| 03615140001939 | HYGITECH | HYGITECH | 2020-11-24 |
| 03615140001960 | HYGITECH | HYGITECH | 2020-11-24 |
| 03615140002028 | HYGITECH | HYGITECH | 2020-11-24 |
| 04582539071042 | Free arm arteo-S(120V) | TOKYO GIKEN INC. | 2020-09-18 |
| 00840018641181 | NORDENT MANUFACTURING INC | NORDENT MANUFACTURING INC | 2020-06-08 |
| 00840018641198 | NORDENT MANUFACTURING INC | NORDENT MANUFACTURING INC | 2020-06-08 |
| 00810032660284 | Isolite, i3 | ZYRIS, INC. | 2019-09-24 |