EIA · Unit, Operative Dental
Dental · 21 CFR 872.6640 · Class 1
Overview
| Product Code | EIA |
|---|---|
| Device Name | Unit, Operative Dental |
| Regulation | 21 CFR 872.6640 |
| Device Class | Class 1 |
| Review Panel | Dental |
| 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 | Midmark Dental Delivery System | Midmark Corporation | Nov 3, 2025 | SESE |
| K251491 | K5 Cart, K5 Mount, K5 Swing | Osstem Implant Company., Ltd. Chair Business | Jul 17, 2025 | SESE |
| K243130 | Integral Dental Unit | Guangdong Yadeng Medical Apparatus Co., Ltd., | Jun 27, 2025 | SESE |
| K242611 | Integral Dental Units | Mipont Medical Equipment Co., Ltd. | May 27, 2025 | SESE |
| K250473 | Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus | Dci International, LLC | Feb 19, 2025 | SESE |
| K242404 | BDC Dental Unit | Bdc Dental Corporation , Ltd. | Feb 7, 2025 | SESE |
| K231297 | Firstar Dental Unit | Firstar Dental Company | Jan 27, 2025 | SESE |
| K233805 | K5 | Osstem Implant Co., Ltd. Chair Business | Sep 3, 2024 | SESE |
| K240754 | N2 | Megagen Implant Co., Ltd. | Mar 21, 2024 | SESE |
| K231845 | Dental unit Model: Mare | Foshan Safety Medical Equipment Co., Ltd. | Feb 28, 2024 | SESE |
| K202963 | ELEC Master, ELEC Master Dual | Mgnewton , Ltd. | May 5, 2023 | SESE |
| K211556 | N2 | Megagen Implant Co., Ltd. | Apr 5, 2023 | SESE |
| K213749 | G7, Dental Operative Unit and Accessories | Shinhung Company, Ltd. | Apr 3, 2023 | SESE |
| K220873 | Perceptive electric dental motor and control unit | Lares Research | Dec 15, 2022 | SESE |
| K213742 | Infinity Pro, Logic, Quality, Sprint | Olsen Indústria E Comércio S.A. | Oct 19, 2022 | SESE |
| K213932 | A-dec 300, A-dec 500 | A-Dec, Inc. | Mar 2, 2022 | SESE |
| K180935 | Infinity / Infinity Cross Flex Dental Systems | Olsen Industria E Comercio S.A. | Feb 5, 2020 | SESE |
| K183347 | K3 | Osstem Implant Co., Ltd. | Sep 4, 2019 | SESE |
| K183121 | Qraypen | AIOBIO Co., Ltd. | Jul 18, 2019 | SESE |
| K173608 | 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
