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FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories3
Latest FDA decision2025-11-21
TypeNumberDevice NameCodeDateActions
510(k) 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)EBI2025-11-21 View
510(k) K240597 TERA HARZ CLEARNXC2024-03-05 View
510(k) K233502 TERA HARZ IIEBF2023-11-01 View
510(k) K223355 Tera Harz ClearNXC2022-11-03 View
510(k) K222414 TERA HARZ DENTUREEBI2022-08-11 View
510(k) K202846 TERA HARZEBF2021-07-15 View

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