DenTek Oral Care Limited
GB-MF-000034440 · United Kingdom · St. Albans, Hertfordshire
DenTek Oral Care Limited is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 11 |
|---|
Authorised representative in the Union: Elara Pharmaservices Europe Ltd.
Devices declared under this manufacturer
- Comfort-Fit Dental Guard
- Dental First Aid Kit
- EKULF NightGuard
- EKULF Tooth Repair Kit
- Essentials Temporary Repair Kit 5+ (1.1g)
- Maximum Protection Dental Guard
- Shiepz™ Anti Tandenknars
- Temparin Max Repair Kit 12+ (2.64g)
- Temparin Max Repair Kit 24+ (2 x 2.64g)
- Temparin Max Repair Kit 5+ (1.1g)
Catalogue references include 01327700101A, 05000200101F, 050023006DSA, 050032006DSG, 050241006DS, 10047701000172.
European nomenclature codes declared: Q0101010203, Q010499.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | DenTek Oral Care, Inc. (US) · FDA 2938386 |
| Devices in EUDAMED | 11 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 11 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 9.1 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | DENTEK ORAL CARE, INC. |
North American profile: Both markets. DenTek Oral Care Limited is registered in both the United States and Canada.