Manufacturer registered with FDA

Royal Dental Laboratory

Shenzhen, China. Lists 4 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator9057339Manufacturer

Device types listed: 4
Brands and models: 4
510(k) clearances: 12020–2020
Markets registered in: 1United States
Establishments: 1China

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Royal Dental Laboratory currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Backing and Facing Artificial TeethELK · Class 1	—	Maker	Veneer	2025
Preformed CrownELZ · Class 1	—	Maker	CROWN, PREFORMED	2003
Preformed Tooth PositionerKMY · Class 1	Retainers, expanders & headgear	Maker	Preformed Tooth Positioner	2018
Sequential AlignerNXC · Class 2	Clear aligners	Maker	Clear Aligner	2020

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Royal Dental Laboratory as the applicant, including filings under its other names.

Decided	510(k)	Device	Device type
8 Jan 2020	K192767	Clear Aligner	NXC Sequential Aligner

Registered establishments

Establishment	Location	What it does
Royal Dental LabFDA reg. 3004086183	Shenzhen Guangdong, China	Manufacturer

Other names on FDA records

Royal Dental Lab

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9057339). 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.