EHZ · Evacuator, Oral Cavity
Dental · 21 CFR 872.6640 · Class 1
Overview
| Product Code | EHZ |
|---|---|
| Device Name | Evacuator, Oral Cavity |
| Regulation | 21 CFR 872.6640 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.
Classification Rationale
Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K973248 | IMTEC BONE COLLECTOR SYSTEM | Imtec Corp. | Nov 19, 1997 | SESE |
| K941164 | TAP EXPRESS EJECTOR | Tap Express, Inc. | May 18, 1994 | SESE |
| K911072 | SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR | A & F Products | May 15, 1991 | SESE |
| K903718 | OROSCOPE MODEL NUMBER COS-100 | Cygnus Instruments, Inc. | Nov 9, 1990 | SESE |
| K892882 | DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102 | Nieusma R & D, Inc. | Jun 23, 1989 | SESE |
| K892881 | DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 | Nieusma R & D, Inc. | Jun 23, 1989 | SESE |
| K880754 | DRI-CLAVE LIQUID KLEENZALL | Columbus Dental Mfg. Co. | May 12, 1988 | SESE |
| K873545 | PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT | Commercial Products & Engineering Co. | Nov 20, 1987 | SESE |
| K874401 | TITANIUM SUCTION TIP | Implant Innovations International, Inc. | Nov 12, 1987 | SESE |
| K864621 | VAC - RITE RIGHT ANGLE ASPIRATOR TUBE & HOLDER | Seldoren , Ltd. | Feb 13, 1987 | SESE |
| K863769 | EVACUATOR TIPS | The Medical Group, Inc. | Oct 30, 1986 | SESE |
| K801682 | SPACELINE HIGH VOLUME EVACUATION HANDPIE | Pacific Dental Corp. | Aug 4, 1980 | SESE |
| K782068 | MVS UNIT, MODEL SEU-8 AND DEU-8, 80 | Dentsply Intl. | Jan 26, 1979 | SESE |
| K781488 | MVS-MODEL SEU-6, DEU-6 | Dentsply Intl. | Sep 27, 1978 | SESE |
| K781486 | STERI-VAC POWER UNITS | Cpac, Inc. | Sep 27, 1978 | SESE |
| K780701 | DENTAL OFFICE ENVIRONMENT CONTROL UNIT | Laminaire Corp. | May 16, 1978 | SESE |
| K770152 | AUTO-RINSE | Dental Innovators, Inc. | Jan 31, 1977 | SESE |
Top Applicants
- Dentsply Intl. — 2 clearances
- Nieusma R & D, Inc. — 2 clearances
- A & F Products — 1 clearance
- Columbus Dental Mfg. Co. — 1 clearance
- Commercial Products & Engineering Co. — 1 clearance
