Nobel Biocare AB
SE-MF-000000009 · Sweden · Göteborg
Nobel Biocare AB is registered in the European database on medical devices as a manufacturer, with 3 516 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 1 209 |
|---|---|
| Class IIb | 2 307 |
Most frequent device types declared: 29004, 29010, 29064, 29989, 31146.
Among these devices, 1 070 are declared sterile, 2 277 implantable, 419 reusable, 27 active.
Devices declared under this manufacturer
- 30° Multi-unit Abutment Xeal™ Conical Connection RP 4.5mm
- Guided Cylinder with Pin CC WP 5.5
- Guided Drill Guide NP to Ø3.2mm
- IOS Base Replica Nobel Biocare N1™ Base Tri RP
- Impression Coping Open Tray NobRpl NP Ø4.5mm
- NPr FCZ Imp Crown ASC CC RP CAD 1-25° s5
- NPr FCZ Imp Crown ASC CC WP w-u 1-25° s6
- NobelActive® Internal NP 3.5x10mm
- NobelActive® TiUltra™ NP 3.5x15mm
- NobelProcera® ASC Ab Zr CC WP Wax-Up 1-25° White
- NobelProcera® Zirconia Implant Crown NB N1™ Base D4 RP
- NobelZygoma™ Pilot Drill 3.5 mm
Showing 12 of 3 516 declared devices.
Catalogue references include 300190, 300248, 301025, 34125, 35882, 37950.
European nomenclature codes declared: P01020101, L159099, P01020180, Q010501, Q010299, Q010207.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | NOBEL BIOCARE AB (SE) · FDA 9611992 |
| Devices in EUDAMED | 3 516 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 3 516 |
|---|---|
| Found in the U.S. device database | 3 354 |
| Share | 95.4 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | NOBEL BIOCARE AB |
What it holds in Canada
| Licences on record | 50 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 15 |
| Class 3 devices | 35 |
| First licensed | 1999-08-31 |
Licence types: Device Family (31), System (14), Device Group Family (3), Single Device (2).
Licensed under: POWERED SURGICAL INSTRUMENTS - STAINLESS STEEL, ZYGOMA SURGICAL INSTRUMENT SYSTEM, NOBEL DIRECT SYSTEM, ABUTMENTS - CERAMIC, RETAINER RINGS - STAINLESS STEEL, HEALING CAPS/COVER PLUGS - POLYMERIC.
North American profile: Both markets. Nobel Biocare AB is registered in both the United States and Canada.