Data / Medical devices / Hong Kong / Diverge Group Inc
Diverge Group Inc: FDA-registered device maker in Hong Kong, Hong Kong, 1 510(k) clearance
Diverge Group Inc is registered with the FDA (registration 3011545197) in Hong Kong, Hong Kong. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 10, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011545197
- Address
- Rm. 1702, Sino Centre, Nathan Rd., Mongkok, Kln., Hong Kong, Hong Kong, NA
- Owner or operator
- Diverge Group Inc (10053393)
- Roles
- Exporter to the US
- First device listed
- November 30, 2016
- Registered through
- 2026
- Brand names listed
- REACH Professional Comfy Picks 60, REACH Professional Floss Picks 90, REACH Professional Floss Picks Mint 2CT, REACH Professional Floss Picks Mint 3CT, REACH Professional Interdental Brush Extra Tight 10, REACH Professional Interdental Brush Extra Tight 2CT, REACH Professional Interdental Brush Tight 10, REACH Professional Interdental Brush Tight 2CT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Floss, Dental | JES | 1 | Exporter to the US | accessdata.fda.gov |
| Mouthguard, Over-The-Counter | OBR | U | Exporter to the US | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Exporter to the US | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Exporter to the US | accessdata.fda.gov |
| Zinc Oxide Eugenol | EMB | 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 |
|---|---|---|---|---|---|---|
| January 10, 2013 | K123849 | NEW COMFORT-FIT DENTAL GUARD | OBR | Substantially Equivalent | Den Tek Oral Care, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Toothbrush, Manual
- All makers of Zinc Oxide Eugenol
- All makers of Mouthguard, Over-The-Counter
- All makers of Pick, Massaging
- All makers of Floss, Dental
Updated January 10, 2013. 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.