Manufacturer registered with FDA
Shenzhen Sunmc Dental Technology Co., Ltd.
Shenzhen, China. Lists 14 dental device types with FDA across 1 registered establishment.
- Device types listed
- 14
- Brands and models
- 20
- 510(k) clearances
- 0as applicant
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Shenzhen Sunmc Dental Technology Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Shenzhen Sunmc Dental Technology Co., Ltd. | 14 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Shenzhen Sunmc Dental Technology Co., Ltd. | 2 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Shenzhen Sunmc Dental Technology Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | Hawley RetainerRetainer | 2025 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | CUSTOMIZED Retainer | 2025 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Aligner removal tool,Retainer removal tool | 2026 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Maker | Denture Case; Retainer Case; Retainer Box;Denture Box,Invisible Braces Box,Mouth Guard Case | 2026 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | Aligner Chewies,Orthodotnic Elastics | 2026 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Orthodontic Wax | 2026 |
| All Precision AttachmentEGG · Class 1 | — | Maker | Attachment, Precision, All Denture Plastic ModelCo/Cr Partial Framework | 2020 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | Alloy, Metal, Base | 2020 |
| Gold-Based Noble Metal AlloyEJT · Class 2 | Dental alloys | Maker | Alloy, gold-based noble metal | 2020 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | Denture, plastic, teeth | 2020 |
| Preformed CrownELZ · Class 1 | — | Maker | Acrylic DentureDental CrownFull Metal CrownImplant CrownPFM Crown | 2020 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | DENTAL NIGHT GUARD | 2025 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Intraoral Scanner | 2025 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | Clear Aligner | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Shenzhen Sunmc Dental Technology Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Shenzhen Meiming Dentistry Technology Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 16 Aug 2022 | K213026 | Clear Aligner | Shenzhen Meiming Dentistry Technology Co., Ltd. | NXC Sequential Aligner |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Shenzhen Sunmc Dental Technology Co., Ltd.FDA reg. 3016998377 | Shenzhen Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10070576). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.