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Basic Information
- Primary DI
- D-OsstellIDxWE
- Basic UDI-DI Code
- B-OsstellIDxWE
- Reference
- 101000
- Device Types
-
Sterilization
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Osstell AB
Additional Description
The Osstell IDx is a fast, non-invasive and easy to use system to determine implant stability and to assess the process of osseointegration โ without jeopardizing the healing process. It provides the accurate, consistent, and objective information needed to make well-founded decisions. It is the only objective quality assurance method that gives you an early warning if osseointegration isnโt progressing as expected, bringing new certainty to you and your patient.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Q0199 | ODONTOLOGY DEVICES - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 843847 MR2 | DQS Medizinprodukte GmbH | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).