Evacuator, Oral Cavity
FDA product code EHZ · Class I (low risk) · 21 CFR 872.6640 · Dental
17510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Dentsply Intl. 2
- Nieusma R & D, Inc. 2
- Dental Innovators, Inc. 1
- Laminaire Corp. 1
- Cpac, Inc. 1
- Pacific Dental Corp. 1
- The Medical Group, Inc. 1
- Seldoren , Ltd. 1
- Implant Innovations International, Inc. 1
- Commercial Products & Engineering Co. 1
- Columbus Dental Mfg. Co. 1
- Cygnus Instruments, Inc. 1
- A & F Products 1
- Tap Express, Inc. 1
- Imtec Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973248 | Imtec Bone Collector SystemEHZ · Traditional | Imtec Corp. | 11/19/1997SE |
| K941164 | Tap Express EjectorEHZ · Traditional | Tap Express, Inc. | 05/18/1994SE |
| K911072 | Super Evacretractor, Disposable Oral EvacuatorEHZ · Traditional | A & F Products | 05/15/1991SE |
| K903718 | Oroscope Model Number COS-100EHZ · Traditional | Cygnus Instruments, Inc. | 11/09/1990SE |
| K892882 | Dental Sani-Sleeve Sterile 100MM X 2200MM #1102EHZ · Traditional | Nieusma R & D, Inc. | 06/23/1989SE |
| K892881 | Dental Sani-Sleeve Sterile 60MM X 1650MM #1101EHZ · Traditional | Nieusma R & D, Inc. | 06/23/1989SE |
| K880754 | Dri-Clave Liquid KleenzallEHZ · Traditional | Columbus Dental Mfg. Co. | 05/12/1988SE |
| K873545 | Portable Field Dental Operating & Treatment UnitEHZ · Traditional | Commercial Products & Engineering Co. | 11/20/1987SE |
| K874401 | Titanium Suction TipEHZ · Traditional | Implant Innovations International, Inc. | 11/12/1987SE |
| K864621 | Vac - Rite Right Angle Aspirator Tube & HolderEHZ · Traditional | Seldoren , Ltd. | 02/13/1987SE |
| K863769 | Evacuator TipsEHZ · Traditional | The Medical Group, Inc. | 10/30/1986SE |
| K801682 | Spaceline High Volume Evacuation HandpieEHZ · Traditional | Pacific Dental Corp. | 08/04/1980SE |
| K782068 | MVS Unit, Model SEU-8 and DEU-8, 80EHZ · Traditional | Dentsply Intl. | 01/26/1979SE |
| K781488 | Mvs-Model SEU-6, DEU-6EHZ · Traditional | Dentsply Intl. | 09/27/1978SE |
| K781486 | Steri-Vac Power UnitsEHZ · Traditional | Cpac, Inc. | 09/27/1978SE |
| K780701 | Dental Office Environment Control UnitEHZ · Traditional | Laminaire Corp. | 05/16/1978SE |
| K770152 | Auto-RinseEHZ · Traditional | Dental Innovators, Inc. | 01/31/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0558-2023 Class II | STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225,Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… | Stradis Medical, LLC dba Stradis Healthcare | 11/02/2022Open, Classified |