Manufacturer
Orca Dental AI
Israel
Markets : Northern Ireland · United States
Approvals : EU – class I · United States (FDA) – 510(k) : 2 · class II · latest in 2026 · see on the FDA website
EU representative : Asterion Regulatory Group (Northern Ireland)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a category to see competitors, a model to open its EUDAMED record.
| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Instruments for extraoral dental radiology - medical device software | Z11030392 | I MDR | EUDAMED record Report an error |
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