Manufacturer registered with FDA

Visionare LLC

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

FDA owner/operator10047752Manufacturer

Device types listed: 2
Brands and models: 2
510(k) clearances: 12018–2018
Markets registered in: 38 registrations outside the US
Establishments: 1United States

510(k) clearances per year, 2007–2026

Registered in 3 markets

Where regulators' registries name Visionare LLC as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	Visionare LLC	1 clearances	2018–2018	Below
Brazil	ANVISA	Manufacturer	VISIONARE LLC	7	2019–2019	Pure Global AI
Colombia	INVIMA	Manufacturer	VISIONARE LLC	1	—	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Visionare 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
Intraosseous Fixation ScrewDZL · Class 2	Maxillofacial plates & screws	Maker	VISIONARE	2019
Bone PlateJEY · Class 2	Maxillofacial plates & screws	Maker	VISIONARE	2019

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 Visionare LLC as the applicant.

Decided	510(k)	Device	Device type
28 Dec 2018	K180204	CranioMaxillofacial Fixation (CMF) System - CMF Visionare	JEY Bone Plate

Registered establishments

Establishment	Location	What it does
VISIONARE LLCFDA reg. 3011196443	Fort Myers, FL, United States	Complaint file establishment, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10047752). 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.