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) → EIA — Unit, Operative Dental # EIA · Unit, Operative Dental _Dental · 21 CFR 872.6640 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA ## Overview - **Product Code:** EIA - **Device Name:** Unit, Operative Dental - **Regulation:** [21 CFR 872.6640](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6640) - **Device Class:** 1 - **Review Panel:** [Dental](/submissions/DE) - **3rd-party reviewable:** yes ## 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 (20 of 284) Showing 20 most recent of 284 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251626](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K251626.md) | Midmark Dental Delivery System | Midmark Corporation | Nov 3, 2025 | SESE | | [K251491](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K251491.md) | K5 Cart, K5 Mount, K5 Swing | Osstem Implant Company., Ltd. Chair Business | Jul 17, 2025 | SESE | | [K243130](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K243130.md) | Integral Dental Unit | Guangdong Yadeng Medical Apparatus Co., Ltd., | Jun 27, 2025 | SESE | | [K242611](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K242611.md) | Integral Dental Units | Mipont Medical Equipment Co., Ltd. | May 27, 2025 | SESE | | [K250473](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K250473.md) | Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus | Dci International, LLC | Feb 19, 2025 | SESE | | [K242404](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K242404.md) | BDC Dental Unit | Bdc Dental Corporation , Ltd. | Feb 7, 2025 | SESE | | [K231297](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K231297.md) | Firstar Dental Unit | Firstar Dental Company | Jan 27, 2025 | SESE | | [K233805](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K233805.md) | K5 | Osstem Implant Co., Ltd. Chair Business | Sep 3, 2024 | SESE | | [K240754](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K240754.md) | N2 | Megagen Implant Co., Ltd. | Mar 21, 2024 | SESE | | [K231845](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K231845.md) | Dental unit Model: Mare | Foshan Safety Medical Equipment Co., Ltd. | Feb 28, 2024 | SESE | | [K202963](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K202963.md) | ELEC Master, ELEC Master Dual | Mgnewton , Ltd. | May 5, 2023 | SESE | | [K211556](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K211556.md) | N2 | Megagen Implant Co., Ltd. | Apr 5, 2023 | SESE | | [K213749](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K213749.md) | G7, Dental Operative Unit and Accessories | Shinhung Company, Ltd. | Apr 3, 2023 | SESE | | [K220873](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K220873.md) | Perceptive electric dental motor and control unit | Lares Research | Dec 15, 2022 | SESE | | [K213742](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K213742.md) | Infinity Pro, Logic, Quality, Sprint | Olsen Indústria E Comércio S.A. | Oct 19, 2022 | SESE | | [K213932](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K213932.md) | A-dec 300, A-dec 500 | A-Dec, Inc. | Mar 2, 2022 | SESE | | [K180935](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K180935.md) | Infinity / Infinity Cross Flex Dental Systems | Olsen Industria E Comercio S.A. | Feb 5, 2020 | SESE | | [K183347](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K183347.md) | K3 | Osstem Implant Co., Ltd. | Sep 4, 2019 | SESE | | [K183121](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K183121.md) | Qraypen | AIOBIO Co., Ltd. | Jul 18, 2019 | SESE | | [K173608](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA/K173608.md) | Forest Dental Unit | Forest Dental Products, Inc. | Aug 17, 2018 | SESE | ## Top Applicants - A-Dec, Inc. — 25 clearances - Aseptico, Inc. — 5 clearances - Trophy Radiologie — 4 clearances - Sirona Dental Systems GmbH — 4 clearances - Sds Dental, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EIA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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