Product code EIA
- Device name
- Unit, Operative Dental
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.6640
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251544 | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) | Lakong Medical Devices Co., Ltd. | 2026-08-07 |
| K251626 | Midmark Dental Delivery System | Midmark Corporation | 2025-11-03 |
| K251491 | K5 Cart, K5 Mount, K5 Swing | Osstem Implant Company., Ltd. Chair Business | 2025-07-17 |
| K243130 | Integral Dental Unit | Guangdong Yadeng Medical Apparatus Co., Ltd., | 2025-06-27 |
| K242611 | Integral Dental Units | Mipont Medical Equipment Co., Ltd. | 2025-05-27 |
| K250473 | Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus | Dci International, LLC | 2025-02-19 |
| K242404 | BDC Dental Unit | Bdc Dental Corporation , Ltd. | 2025-02-07 |
| K231297 | Firstar Dental Unit | Firstar Dental Company | 2025-01-27 |
| K233805 | K5 | Osstem Implant Co., Ltd. Chair Business | 2024-09-03 |
| K240754 | N2 | Megagen Implant Co., Ltd. | 2024-03-21 |
| K231845 | Dental unit Model: Mare | Foshan Safety Medical Equipment Co., Ltd. | 2024-02-28 |
| K202963 | ELEC Master, ELEC Master Dual | Mgnewton , Ltd. | 2023-05-05 |
| K211556 | N2 | Megagen Implant Co., Ltd. | 2023-04-05 |
| K213749 | G7, Dental Operative Unit and Accessories | Shinhung Company, Ltd. | 2023-04-03 |
| K220873 | Perceptive electric dental motor and control unit | Lares Research | 2022-12-15 |
| K213742 | Infinity Pro, Logic, Quality, Sprint | Olsen Indústria E Comércio S.A. | 2022-10-19 |
| K213932 | A-dec 300, A-dec 500 | A-Dec, Inc. | 2022-03-02 |
| K180935 | Infinity / Infinity Cross Flex Dental Systems | Olsen Industria E Comercio S.A. | 2020-02-05 |
| K183347 | K3 | Osstem Implant Co., Ltd. | 2019-09-04 |
| K183121 | Qraypen | AIOBIO Co., Ltd. | 2019-07-18 |
| K173608 | Forest Dental Unit | Forest Dental Products, Inc. | 2018-08-17 |
| K171872 | P50 Series Dental Operative Unit and Accessories | Pelton & Crane | 2018-04-26 |
| K152830 | K3 | Osstem Implant Co., Ltd. | 2017-04-20 |
| K161734 | Vanguard Dental Unit | Ritter Concept GmbH | 2016-12-09 |
| K161488 | ESTETICA Dental Treatment Unit and Accessories | Kaltenbach & Voigt GmbH | 2016-12-08 |
| K151996 | TAURUS C1 | Shinhung Company, Ltd. | 2016-01-22 |
| K152100 | Evogue Dental Unit | Takara Belmont Corporation | 2016-01-22 |
| K143696 | Spirit | Pelton & Crane | 2015-09-18 |
| K151045 | TENEO Dental Treatment Unit and Accessories | Sirona Dental Systems GmbH | 2015-07-24 |
| K150909 | INTEGO Family and Accesories | Sirona Dental Systems GmbH | 2015-07-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00841709109812 | Midmark | MIDMARK CORPORATION | 2026-09-28 |
| 00841709109805 | Midmark | MIDMARK CORPORATION | 2026-09-28 |
| 00841709111853 | Midmark | MIDMARK CORPORATION | 2026-09-28 |
| 00841709111846 | Midmark | MIDMARK CORPORATION | 2026-09-28 |
| 00841709110061 | Midmark | MIDMARK CORPORATION | 2026-09-28 |
| 00841709110054 | Midmark | MIDMARK CORPORATION | 2026-09-28 |
| 00841709110030 | Midmark | MIDMARK CORPORATION | 2026-09-28 |
| 00841709109881 | Midmark | MIDMARK CORPORATION | 2026-09-28 |
| 00841709109874 | Midmark | MIDMARK CORPORATION | 2026-09-28 |
| 00841709109850 | Midmark | MIDMARK CORPORATION | 2026-09-28 |
| 00841709109843 | Midmark | MIDMARK CORPORATION | 2026-09-28 |
| 00850043433255 | E300 Hygiene Delivery System | Engle Dental Systems, LLC | 2022-12-09 |
| 00850043433248 | AS1 360 Delivery System | Engle Dental Systems, LLC | 2022-12-09 |
| 00850043433231 | E300 360 Delivery System | Engle Dental Systems, LLC | 2022-12-09 |
| 00850043433156 | Hygiene Flip Top Cart | Engle Dental Systems, LLC | 2022-12-09 |
| 00850043433149 | Dr. Flip Top Cart | Engle Dental Systems, LLC | 2022-12-09 |
| 00850043433132 | Asst Tabletop Cart | Engle Dental Systems, LLC | 2022-12-09 |
| 00850043433125 | Dr./Asst Tabletop Cart | Engle Dental Systems, LLC | 2022-12-09 |
| 00850043433118 | Asst Silver Cart | Engle Dental Systems, LLC | 2022-12-09 |
| 00850043433101 | Asst Platinum Cart | Engle Dental Systems, LLC | 2022-12-09 |
| 00850043433095 | Platinum Mobile Cart | Engle Dental Systems, LLC | 2022-12-09 |
| 00850043433088 | Gold Mobile Cart | Engle Dental Systems, LLC | 2022-12-09 |
| 00850043433071 | Silver Mobile Cart | Engle Dental Systems, LLC | 2022-12-09 |
| 00850043433064 | Rear Delivery | Engle Dental Systems, LLC | 2022-12-09 |
| 00850043433057 | Assistant Wall Mount Arm | Engle Dental Systems, LLC | 2022-12-09 |
| 00850043433040 | AS1 Wall Mnt Rear Delivery | Engle Dental Systems, LLC | 2022-12-09 |
| 00850043433033 | AS1 Dr./Asst Rear Delivery | Engle Dental Systems, LLC | 2022-12-09 |
| 00850043433026 | Cabinet Asst Only Rear Delivery | Engle Dental Systems, LLC | 2022-12-09 |
| 00850043433019 | Cabinet Side Mount Rear Delivery | Engle Dental Systems, LLC | 2022-12-09 |
| 00850043433002 | Cabinet Top Mount Rear Delivery | Engle Dental Systems, LLC | 2022-12-07 |