510(k) K253681 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)
| Applicant | Graphy, Inc., Seoul, KR |
| Decision | Substantially Equivalent, Nov 21, 2025 |
| Received | Nov 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253681
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.