Manufacturer registered with FDA

TAV Medical

Shlomi, Israel. Lists 2 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.

FDA owner/operator10084690Contract manufacturer

Device types listed: 2
Brands and models: 2
510(k) clearances: 32018–2019
Markets registered in: 25 registrations outside the US
Establishments: 1Israel

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name TAV Medical as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: IsraelOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	TAV Medical	3 clearances	2018–2019	Below
Israel	AMAR	Manufacturer	TAV Medical Ltd.Tav Medical Ltd.	5	—	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 TAV Medical currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Endosseous Dental Implant AbutmentNHA · Class 2	Implant abutments	Maker	TAV Dental Implant System	2022
Root-Form Endosseous ImplantDZE · Class 2	Dental implants	Maker	TAV Dental Implant System	2022

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 TAV Medical as the applicant.

Decided	510(k)	Device	Device type
29 Oct 2019	K192053	W Zirconia Implants	DZE Root-Form Endosseous Implant
6 Nov 2018	K172668	W Zirconia Implants	DZE Root-Form Endosseous Implant
10 Feb 2018	K170131	TAV Medical Dental Implants System	DZE Root-Form Endosseous Implant

Registered establishments

Establishment	Location	What it does
TAV MedicalFDA reg. 3012635238	Shlomi/Bar Lev Northern, Israel	Contract manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10084690). 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.