510(k) K021378 ยท EHD Unit, X-Ray, Extraoral With Timer
PORTABLE HDX INTRAORAL X-RAY
| Applicant | Dentalez Group, Lancaster PA, US |
| Decision | Substantially Equivalent, Jun 7, 2002 |
| Received | May 1, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021378
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Den-Tal-Ez Inc,Star Dental Div Portable HDX Intraoral Dental X-Ray. Extraoral Source X-ray System. Part number 300020 Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.