510(k) K170813 ยท OAS X-Ray, Tomography, Computed, Dental
ORTHOPANTOMOGRAPH OP 3D
| Applicant | Palodex Group OY, Tuusula, FI |
| Decision | Substantially Equivalent, Apr 7, 2017 |
| Received | Mar 17, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170813
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 31, 2018 | KaVo Dental Technologies LLC cone-beam CT system Open, Classified |
OAS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.