Registered with FDA

Veenak International Limited

BIRMINGHAM, United Kingdom. Lists 5 dental device types with FDA across 1 registered establishment.

FDA owner/operator10058153Foreign exporter
Device types listed
5
Brands and models
0
510(k) clearances
0as applicant
Markets registered in
1United States
Establishments
1United Kingdom

Devices listed with FDA

What Veenak International Limited currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Powered Bone DrillDZI · Class 2Surgical drills & motorsLister—2019
Oral Irrigation UnitEFS · Class 1Oral irrigatorsLister—2026
Ultrasonic ScalerELC · Class 2Ultrasonic scalersLister—2019
Preformed CrownELZ · Class 1—Lister—2019
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsLister—2019

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

Also lists devices cleared under other names

Veenak International Limited lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Satelec - Acteon Group (1), Satelec (1).

Decided510(k)DeviceApplicantDevice type
11 Mar 2014K132322NEWTRON P5 XS B.LEDSatelec - Acteon GroupELC Ultrasonic Scaler
11 Dec 2009K091331PIEZOTOME 2SatelecDZI Powered Bone Drill

Registered establishments

EstablishmentLocationWhat it does
VEENAK INTERNATIONAL LIMITEDFDA reg. 3013298431BIRMINGHAM, United KingdomForeign exporter

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10058153). 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.