Data / Medical devices / Hong Kong / Modern Dental Global Solutions Limited
Modern Dental Global Solutions Limited: FDA-registered device maker in Hong Kong, Hong Kong, 11 510(k) clearances
Modern Dental Global Solutions Limited is registered with the FDA (registration 3015674959) in Hong Kong, Hong Kong. It lists 14 device types. The FDA files 11 510(k) clearances under its listings, the newest dated September 1, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015674959
- Address
- Room 1701-07, 09-16 CEO Tower, 77 Wing Hong Street, Cheung Sha Wan, Kowloon, Hong Kong, Hong Kong, 999077
- Owner or operator
- MODERN DENTAL LABORATORY CO.LTD. (9059261)
- Roles
- Exporter to the US
- First device listed
- March 6, 2008
- Registered through
- 2026
- Brand names listed
- ACRYLIC DENTURE, Anti-Snoring Device, Basic retainer, Bleaching retainer, COMPOSITE RESIN CROWN AND BRIDGE, Calypso restoration, EMA Custom, EMA First Step, EMAX Crown / Bridge and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Exporter to the US | accessdata.fda.gov |
| Aligner, Sequential | NXC | 2 | Exporter to the US | accessdata.fda.gov |
| Dentures, Full | NSL | N | Exporter to the US | accessdata.fda.gov |
| Dentures, Partial | NSK | N | Exporter to the US | accessdata.fda.gov |
| Device, Anti-Snoring | LRK | 2 | Exporter to the US | accessdata.fda.gov |
| Device, Jaw Repositioning | LQZ | 2 | Exporter to the US | accessdata.fda.gov |
| Maintainer, Space Preformed, Orthodontic | DYT | 1 | Exporter to the US | accessdata.fda.gov |
| Prosthesis, Orthodontic | NSR | N | Exporter to the US | accessdata.fda.gov |
| Restoration, Base Metal | NSQ | N | Exporter to the US | accessdata.fda.gov |
| Restoration, Noble Metal | NSJ | N | Exporter to the US | accessdata.fda.gov |
| Restoration, Porcelain | NSP | N | Exporter to the US | accessdata.fda.gov |
| Restoration, Porcelain-Fused-To-Metal | NSO | N | Exporter to the US | accessdata.fda.gov |
| Restoration, Resin, Crown And Bridge | NSN | N | Exporter to the US | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 1, 2023 | K231884 | TRIOCLEAR System | NXC | Substantially Equivalent | Modern Dental Laboratory (Dg) Co., Ltd. | accessdata.fda.gov |
| May 10, 2023 | K223624 | Emerald Herbst | LRK | Substantially Equivalent | Island Dental Lab, Inc Dba Emerald Dental | accessdata.fda.gov |
| July 6, 2021 | K193622 | TRIOCLEAR System | NXC | Substantially Equivalent | Perfection Aligner System Hong Kong Limited | accessdata.fda.gov |
| February 5, 2020 | K192127 | Respire Pink AT (Hard, Hard/Soft, EF) | LRK | Substantially Equivalent | Respire Medical Holdings | accessdata.fda.gov |
| December 7, 2015 | K152292 | Respire Blue Series-EF | LRK | Substantially Equivalent | Respire Medical Holding | accessdata.fda.gov |
| August 27, 2015 | K150572 | Respire Pink Series-Herbst-EF | LRK | Substantially Equivalent | Respire Medical Holding | accessdata.fda.gov |
| April 25, 2014 | K132933 | THE MOSES ELITE APPLIANCE | LRK | Substantially Equivalent | Allen J. Moses, Dds, Ltd. | accessdata.fda.gov |
| September 9, 2013 | K131138 | RESPIRE PINK SERIES - HERBST | LRK | Substantially Equivalent | Respire Medical | accessdata.fda.gov |
| August 23, 2011 | K111207 | RESPIRE BLUE SERIES | LRK | Substantially Equivalent | Respire Medical | accessdata.fda.gov |
| May 12, 2010 | K093710 | THE MOSES APPLIANCE | LRK | Substantially Equivalent | Allen J. Moses, Dds, Ltd. | accessdata.fda.gov |
| September 29, 1997 | K971794 | ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE | LRK | Substantially Equivalent | Frantz Design, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Anti-Snoring
- All makers of Restoration, Base Metal
- All makers of Aligner, Sequential
- All makers of Restoration, Noble Metal
- All makers of Dentures, Full
- All makers of Restoration, Porcelain-Fused-To-Metal
Updated September 1, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.