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) → DYN — Mouthpiece, Saliva Ejector # DYN · Mouthpiece, Saliva Ejector _Dental · 21 CFR 872.6640 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/DYN ## Overview - **Product Code:** DYN - **Device Name:** Mouthpiece, Saliva Ejector - **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 (18 of 18) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K940769](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/DYN/K940769.md) | DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR | Terraflex | Aug 17, 1994 | SESE | | [K935758](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/DYN/K935758.md) | HYGOFLEX SALIVA-EJECTOR | J.H.Orsing AB | Mar 21, 1994 | SESE | | [K935616](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/DYN/K935616.md) | SALIVA EJECTOR DISPOSABLE | Asa Instruments S.R.L. | Mar 21, 1994 | SESE | | [K924211](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/DYN/K924211.md) | EJECTOR | Glenroe Technologies | Mar 31, 1993 | SESE | | [K920492](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/DYN/K920492.md) | HIGH VAC | Hygoplastic, Inc. | May 11, 1992 | SESE | | [K921117](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/DYN/K921117.md) | MINIDAM | Delsan Dental Systems | May 5, 1992 | SESE | | [K900631](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/DYN/K900631.md) | SALIVA ABSORBER - DENTAL | Kab Gloves Unltd. | Apr 4, 1990 | SESE | | [K871315](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/DYN/K871315.md) | ORAL ASPIRATOR | Endovations | Apr 15, 1987 | SESE | | [K870599](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/DYN/K870599.md) | TIP, DENTAL SUCTION APPARATUS | Military Engineering, Inc. | Mar 23, 1987 | SESE | | [K864300](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/DYN/K864300.md) | SILIVA EJECTOR/ORAL CAVITY EVACUATOR | Ardent Intl., Inc. | Nov 24, 1986 | SESE | | [K863768](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/DYN/K863768.md) | SALIVA EJECTORS | The Medical Group, Inc. | Oct 27, 1986 | SESE | | [K863163](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/DYN/K863163.md) | ULS 8-86 | American Instrument Manufacturer'S, Inc. | Sep 22, 1986 | SESE | | [K861934](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/DYN/K861934.md) | SALIVA EJECTOR | Carlisle Laboratories, Inc. | Jun 9, 1986 | SESE | | [K801927](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/DYN/K801927.md) | SILENTSLEEP | Slumber Research, Inc. | Nov 14, 1980 | SESE | | [K800210](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/DYN/K800210.md) | TONGUE HOLDER/SALIVA EJECTOR | Unitek Corp. | Feb 6, 1980 | SESE | | [K781592](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/DYN/K781592.md) | SURGICAL ASPIRATOR TIPS | Henry Schein, Inc. | Dec 4, 1978 | SESE | | [K761264](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/DYN/K761264.md) | OPTIONS FOR STAR DENTAL OPUS I | Syntex Corp. | Dec 23, 1976 | SESE | | [K760620](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/DYN/K760620.md) | SALIVA EJECTOR | Lorvic Corp. | Sep 21, 1976 | SESE | ## Top Applicants - Unitek Corp. — 1 clearance - The Medical Group, Inc. — 1 clearance - Terraflex — 1 clearance - Syntex Corp. — 1 clearance - Slumber Research, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/DYN](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/DYN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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