Manufacturer registered with FDA

5 Axis Dental Inc.

Whitby, Canada. Lists 2 dental device types with FDA across 1 registered establishment.

FDA owner/operator10044030Manufacturer
Device types listed
2
Brands and models
3
510(k) clearances
0as applicant
Markets registered in
1United States
Establishments
1Canada

Devices listed with FDA

What 5 Axis Dental Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Backing and Facing Artificial TeethELK · Class 1—Maker
Artificial teeth--coping, crown, inlay, onlay, veneer
2015
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker
Implant Scan AbutmentScanning Jig
2014

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

Registered establishments

EstablishmentLocationWhat it does
5 AXIS DENTAL INC.FDA reg. 3008184555Whitby Ontario, CanadaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10044030). 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.