K253681

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)

510(k) number: K253681
Device name: 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. KR
Product code: EBI — Resin, Denture, Relining, Repairing, Rebasing
Decision date: 2025-11-21
Date received: 2025-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Flag: Third-party review
Advisory committee: Dental

PDFDownload 510(k) SummaryArchived here · 12.2 MB · U.S. public domain

Also available from FDA: K253681.pdf

Official FDA record: K253681

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.