Royal Dental Lab
ChinaFDA applicant, unverified FDA FEI 3004086183
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Royal Dental Lab makes
Royal Dental Lab manufactures clear aligner systems designed for orthodontic treatment, including custom-fitted dental appliances used to gradually reposition teeth.
The company’s products are regulated as Class II medical devices in the US and are listed under the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
- Registry: GUDID
Clear Aligner Ref K192767
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3004086183
- DUNS number
- 529128636
- Address
- F/1, 2, 3, 5, 6, Building 2, No. 4 West Area, Shenzhen Guangdong
- [email protected]
- Phone
- +86075589501914
Frequently asked questions
How many devices does Royal Dental Lab have in the registry?
The registry currently lists 2 devices for Royal Dental Lab. Devices recorded under merged duplicate company entries are counted once.
Which registries list Royal Dental Lab's devices?
Among its 2 most recently registered devices, Royal Dental Lab has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Royal Dental Lab's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Royal Dental Lab's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Royal Dental Lab in the registry?
The most recently registered devices listed for Royal Dental Lab include NA V1.0 and Clear Aligner.