Manufacturer registered with FDA
Modern Dental Laboratory Co., Ltd.
Dongguan, China. Lists 7 dental device types with FDA across 4 registered establishments, and holds 2 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 18
- 510(k) clearances
- 22023–2024
- Markets registered in
- 631 registrations outside the US
- Establishments
- 4China, Hong Kong SAR China, Vietnam
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Modern Dental Laboratory 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 | Modern Dental Laboratory Co., Ltd. | 2 clearances | 2023–2024 | Below |
| Canada | Health Canada | Registration holder | MODERN DENTAL LABORATORY (DG) CO., LTD. | 15 | 2021–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Modern Dental Laboratory (DG) Co Ltd | 7 | 2024–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Modern Dental Laboratory Co., Ltd.Modern Dental Laboratory (DG) Co., Ltd. | 5 | 2020–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Modern Dental Laboratory (DG) Co., Ltd. | 2 | 2024–2024 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Modern Dental Laboratory (DG) 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 Modern Dental Laboratory 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 |
|---|---|---|---|---|
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | Anti-Snoring DeviceEMA Custom, EMA First StepEmerald HerbstMoses ApplianceRespire Pink AT (Hard, Hard/Soft, EF)THE MOSES ELITE APPLIANCE | 2010 |
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | TRIOCLEAR System | 2021 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Basic retainerBleaching retainerEcodont retainerFinishing retainerFixed RetainerSmartfix retainer | 2010 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Lab screwSurgical Guide | 2017 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | DESS Dental Smart Solutions | 2015 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Appliance | 2023 |
| Jaw Repositioning DeviceLQZ · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | Emerald Herbst | 2023 |
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
Modern Dental Laboratory 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: Respire Medical Holding (2), Allen J. Moses, Dds, Ltd. (2), Respire Medical, LLC (2), Island Dental Lab, Inc Dba Emerald Dental (1), Perfection Aligner System Hong Kong Limited (1), Respire Medical Holdings (1), Frantz Design, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 10 May 2023 | K223624 | Emerald Herbst | Island Dental Lab, Inc Dba Emerald Dental | LRK Anti-Snoring Device |
| 6 Jul 2021 | K193622 | TRIOCLEAR System | Perfection Aligner System Hong Kong Limited | NXC Sequential Aligner |
| 5 Feb 2020 | K192127 | Respire Pink AT (Hard, Hard/Soft, EF) | Respire Medical Holdings | LRK Anti-Snoring Device |
| 7 Dec 2015 | K152292 | Respire Blue Series-EF | Respire Medical Holding | LRK Anti-Snoring Device |
| 27 Aug 2015 | K150572 | Respire Pink Series-Herbst-EF | Respire Medical Holding | LRK Anti-Snoring Device |
| 25 Apr 2014 | K132933 | THE MOSES ELITE APPLIANCE | Allen J. Moses, Dds, Ltd. | LRK Anti-Snoring Device |
| 9 Sep 2013 | K131138 | RESPIRE PINK SERIES - HERBST | Respire Medical, LLC | LRK Anti-Snoring Device |
| 23 Aug 2011 | K111207 | RESPIRE BLUE SERIES | Respire Medical, LLC | LRK Anti-Snoring Device |
| 12 May 2010 | K093710 | THE MOSES APPLIANCE | Allen J. Moses, Dds, Ltd. | LRK Anti-Snoring Device |
| 29 Sep 1997 | K971794 | ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE | Frantz Design, Inc. | LRK Anti-Snoring Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Aceso Dental Laboratory Company LimitedFDA reg. 3019793783 | An Phuoc Ward Dong Nai, Vietnam | Contract manufacturer, Manufacturer |
| Modern Dental Global Solutions LimitedFDA reg. 3015674959 | Hong Kong, Hong Kong SAR China | Foreign exporter |
| Modern Dental International Trading LimitedFDA reg. 3010022489 | Hong Kong, Hong Kong SAR China | Foreign exporter |
| Modern Dental Laboratory (DG) Co., Ltd.FDA reg. 3013950969 | Dongguan Guangdong, China | Contract manufacturer, Manufacturer |
Other names on FDA records
Modern Dental Laboratory (DG) Co., Ltd. · Aceso Dental Laboratory Company Limited · Modern Dental International Trading Limited · Modern Dental Global Solutions Limited
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9059261). 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.