Manufacturer registered with FDA

Sun Dental Laboratories, LLC

Saint Petersburg, FL, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator9065239Specification developer

Device types listed: 2
Brands and models: 2
510(k) clearances: 12019–2019
Markets registered in: 1United States
Establishments: 1United States

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Sun Dental Laboratories, LLC currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Orthodontic Plastic BracketDYW · Class 2	Orthodontic brackets	Maker	SunClear Aligner	2020
Sequential AlignerNXC · Class 2	Clear aligners	Maker	SunClear 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 Sun Dental Laboratories, LLC as the applicant.

Decided	510(k)	Device	Device type
16 Dec 2019	K190394	SunClear Aligner system	NXC Sequential Aligner

Registered establishments

Establishment	Location	What it does
SUN DENTAL LABORATORIES LLCFDA reg. 3006430881	Saint Petersburg, FL, United States	Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9065239). 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.