TeKne Dental srl
IT-MF-000026680 · Italy · CALENZANO
TeKne Dental srl is registered in the European database on medical devices as a manufacturer, with 38 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 38 |
|---|
Most frequent device types declared: CURING LAMP, RAPID COUPLING, SILICONE HOSE.
Among these devices, 1 are declared active.
Devices declared under this manufacturer
- 3 HOLE SILICONE HOSE
- 4 HOLE SILICONE HOSE
- 5 HOLE SILICONE HOSE
- DEFINITIVE AND BIEN AIR MC3 HOSE
- DEFINITIVE AND BIEN-AIR MC3 HOSE
- DEFINITIVE LED AND BIEN-AIR MC3 LK/LED HOSE
- DEFINITIVE LED AND BIEN-AIR MC3 LK/LED SILICONE HOSE IN LIGHT GREY COL
- DOUBLE-FUNCTION CONNECTOR FOR BIEN-AIR MC3 ELECTRIC MOTORS OR TURBINES
- ELECTRIFIED 4 HOLE CONNECTOR
- GYROFLEX
- GYROFLEX LED
- M40 HOSE
Showing 12 of 38 declared devices.
Catalogue references include 316.30, 316.62.09, 322.43.00I, 322.43.01, 322.44.90, 322.63.90.
European nomenclature codes declared: Z12110180, Z12119003.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 38 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 38 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. TeKne Dental srl was not found in either the U.S. or the Canadian register.