Manufacturer registered with FDA

Blue Dent Dental

Pirassununga, Brazil. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10055653ManufacturerRepacker / relabeler

Device types listed: 2
Brands and models: 2
510(k) clearances: 12018–2018
Markets registered in: 1United States
Establishments: 1Brazil

510(k) clearances per year, 2007–2026

Devices listed with FDA

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

Device type	Category	Role	Brands and models	Listed since
Resin Temporary Crown and BridgeEBG · Class 2	Temporary crown & bridge materials	Maker	CROWN AND BRIDGE, TEMPORARY, RESIN	2018
Teeth Plastic DentureELM · Class 2	Denture resins & teeth	Maker	Denture, plastic, teeth	2017

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 Blue Dent Dental as the applicant.

Decided	510(k)	Device	Device type
13 Dec 2018	K182065	EVOLUX CAD/CAM PMMA BLOCKS	EBG Resin Temporary Crown and Bridge

Registered establishments

Establishment	Location	What it does
BLUE DENT DENTALFDA reg. 3011618875	Pirassununga Sao Paulo, Brazil	Manufacturer, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10055653). 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.