Modern Dental Laboratory (DG) Co., Ltd.
Manufacturer and brand owner in Dongguan, Guangdong, China. 15 device types, 53 products catalogued, 2 clearances.
Modern Dental Laboratory (DG) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Dentures, Full, Dentures, Partial and 13 other device types. 29 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2008.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3013950969 |
| FEI number | 3013950969 |
| DUNS | 551746187 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 现代牙科技术(东莞)有限公司 |
|---|---|
| Unified social credit code | 91441900MA4UN3KR3A |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | Modern Dental Industrial Park, No. 7 and No.9, Nantou Road, Songshan Lake Hi-Tech Industrial Zone |
| Postal code | 523000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | Class 2 | DESS Dental Smart Solutions | 2015 | 15 |
| Accessories, Implant, Dental, Endosseous | Class 1 | Surgical Guide, Lab screw | 2017 | 70 |
| Aligner, Sequential | Class 2 | TRIOCLEAR System | 2021 | 14 |
| Dentures, Full | Class N | Immediate Denture, Acrylic Denture, Full Denture | 2008 | 50 |
| Dentures, Partial | Class N | Partial Denture, Removable Partial Denture, Flexible Denture | 2008 | 55 |
| Device, Anti-Snoring | Class 2 | Respire Pink AT (Hard, Hard/Soft, EF), EMA Custom, EMA First Step, THE Moses Elite Appliance, Moses Appliance, Anti-Snoring Device, Emerald Herbst | 2010 | 8 |
| Device, Jaw Repositioning | Class 2 | Emerald Herbst | 2023 | 4 |
| Maintainer, Space Preformed, Orthodontic | Class 1 | Smartfix retainer, Ecodont retainer, Basic retainer, Fixed Retainer, Bleaching retainer, Finishing retainer | 2010 | 18 |
| Prosthesis, Orthodontic | Class N | splint, Screw Appliance, ZenSplint, Orthodontic Appliance | 2012 | 29 |
| Restoration, Base Metal | Class N | Metal Restoration ( Base Metal) | 2012 | 43 |
| Restoration, Noble Metal | Class N | Metal Restoration (Noble Metal) | 2012 | 42 |
| Restoration, Porcelain | Class N | Full Ceramic Restoration, Porcelain Restoration, EMAX Crown / Bridge, Zirconia Crown / Bridge, FMZ restoration, Calypso restoration and 3 more | 2008 | 50 |
| Restoration, Porcelain-Fused-To-Metal | Class N | Porcelain Fused to Metal Restoration | 2012 | 50 |
| Restoration, Resin, Crown And Bridge | Class N | Composite Resin Crown AND Bridge, Temporary Crown AND Bridge | 2008 | 35 |
| Wire, Orthodontic | Class 1 | Orthodontic Appliance | 2023 | 43 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Trioclear System | NXC | 4 |
| Anti-snoring, restoration | LRK | 4 |
| Anti-snoring, splint | LRK | 2 |
| Anti-snoring, denture, splint | LRK | 2 |
| Anti-snoring, denture | LRK | 2 |
| Pink EF Series,Splint | LRK | 1 |
| Surgical Guide | NDP | 1 |
| Pink Series,Splint | LRK | 1 |
| Blue Series,Splint | LRK | 1 |
| Moses appliance,Dentures, partial | LRK | 1 |
| Pink Series,Retainer | LRK | 1 |
| Respire Pink AT Series,Retainer | LRK | 1 |
| The Moses TM Appliance | LRK | 1 |
| Respire Pink AT Series | LRK | 1 |
| Blue EF Series | LRK | 1 |
| Elastic Mandibular Advancement (EMA) appliance | LRK | 1 |
| Senture, surgical guide | NDP | 1 |
| Respire Pink AT Series,Splint | LRK | 1 |
| Orthodontic retainer | DYT | 1 |
| Pink EF Series | LRK | 1 |
| Orthodontic Appliance | DZC | 1 |
| Blue EF Series,Splint | LRK | 1 |
| Blue EF Series,Retainer | LRK | 1 |
| Blue Series | LRK | 1 |
| Pink EF Series,Retainer | LRK | 1 |
| Blue Series,Retainer | LRK | 1 |
| Denture,restoration,orthodontic,anti-snoring,orthodontic | LRK | 1 |
| Pink Series | LRK | 1 |
| EMA appliance,Dentures, partial | LRK | 1 |
Clearances
2 clearances name Modern Dental Laboratory (DG) Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K231210 | 2024-03-05 | NHA | Traditional | This company |
| K231884 | 2023-09-01 | NXC | Special | This company |
| K193622 | 2021-07-06 | NXC | Traditional | Perfection Aligner System Hong Kong Limited |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2016 |
|---|---|
| Factory area | 27543 |
| Main products | Dental prosthetics, Dental laboratory services |
| Certifications | ISO 9001, ISO 13485 |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.