Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart G — Miscellaneous Devices](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices) → [21 CFR 872.6640](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6640) → EHZ — Evacuator, Oral Cavity # EHZ · Evacuator, Oral Cavity _Dental · 21 CFR 872.6640 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHZ ## Overview - **Product Code:** EHZ - **Device Name:** Evacuator, Oral Cavity - **Regulation:** [21 CFR 872.6640](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6640) - **Device Class:** 1 - **Review Panel:** [Dental](/submissions/DE) ## 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](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHZ/K973248.md) | IMTEC BONE COLLECTOR SYSTEM | Imtec Corp. | Nov 19, 1997 | SESE | | [K941164](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHZ/K941164.md) | TAP EXPRESS EJECTOR | Tap Express, Inc. | May 18, 1994 | SESE | | [K911072](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHZ/K911072.md) | SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR | A & F Products | May 15, 1991 | SESE | | [K903718](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHZ/K903718.md) | OROSCOPE MODEL NUMBER COS-100 | Cygnus Instruments, Inc. | Nov 9, 1990 | SESE | | [K892882](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHZ/K892882.md) | DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102 | Nieusma R & D, Inc. | Jun 23, 1989 | SESE | | [K892881](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHZ/K892881.md) | DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 | Nieusma R & D, Inc. | Jun 23, 1989 | SESE | | [K880754](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHZ/K880754.md) | DRI-CLAVE LIQUID KLEENZALL | Columbus Dental Mfg. Co. | May 12, 1988 | SESE | | [K873545](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHZ/K873545.md) | PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT | Commercial Products & Engineering Co. | Nov 20, 1987 | SESE | | [K874401](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHZ/K874401.md) | TITANIUM SUCTION TIP | Implant Innovations International, Inc. | Nov 12, 1987 | SESE | | [K864621](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHZ/K864621.md) | VAC - RITE RIGHT ANGLE ASPIRATOR TUBE & HOLDER | Seldoren , Ltd. | Feb 13, 1987 | SESE | | [K863769](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHZ/K863769.md) | EVACUATOR TIPS | The Medical Group, Inc. | Oct 30, 1986 | SESE | | [K801682](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHZ/K801682.md) | SPACELINE HIGH VOLUME EVACUATION HANDPIE | Pacific Dental Corp. | Aug 4, 1980 | SESE | | [K782068](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHZ/K782068.md) | MVS UNIT, MODEL SEU-8 AND DEU-8, 80 | Dentsply Intl. | Jan 26, 1979 | SESE | | [K781488](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHZ/K781488.md) | MVS-MODEL SEU-6, DEU-6 | Dentsply Intl. | Sep 27, 1978 | SESE | | [K781486](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHZ/K781486.md) | STERI-VAC POWER UNITS | Cpac, Inc. | Sep 27, 1978 | SESE | | [K780701](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHZ/K780701.md) | DENTAL OFFICE ENVIRONMENT CONTROL UNIT | Laminaire Corp. | May 16, 1978 | SESE | | [K770152](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHZ/K770152.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHZ](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EHZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com