510(k) K220329 ยท EBF Material, Tooth Shade, Resin
G-CAM
| Applicant | Graphenano Dental S.L., Yecla, ES |
| Decision | Substantially Equivalent, Aug 16, 2022 |
| Received | Feb 4, 2022 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K220329
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2024 | GRAPHENANO DENTAL SL GRAPHENANO DENTAL G-CAM, Product Codes:
a) 95 Multichroma 14LB2, REF GC00089;
b) 95 Multichroma 24LA2, REF GC00112;
c) 95 Multichroma 20LA1, REF GC00130;
d) 95 Multichroma 24LC2, REF GC00090;
e) 9 Open, Classified |
EBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.