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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) by Graphy, Inc. — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2025
Date Received
November 21, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
Review Panel
DE
Submission Type

Other clearances by Graphy, Inc.

  • K240597 — TERA HARZ CLEAR (March 5, 2024)
  • K233502 — TERA HARZ II (November 1, 2023)
  • K223355 — Tera Harz Clear (November 3, 2022)
  • K222414 — TERA HARZ DENTURE (August 11, 2022)
  • K202846 — TERA HARZ (July 15, 2021)

Other clearances for product code EBI

  • K253365 — LuxCreo Flexible Partial Denture Resin (November 25, 2025)
  • K253324 — UltraPrint-Dental Denture UV (November 20, 2025)
  • K252430 — Freeprint® denture flex (October 30, 2025)
  • K252035 — DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink p (September 17, 2025)
  • K250302 — Flexible Partial Resin (June 25, 2025)
  • K242897 — Partial Flex (June 3, 2025)
  • K250489 — FP3D (May 20, 2025)
  • K250617 — Apex Flex (April 29, 2025)
  • K243356 — Asiga DentaBASE (April 11, 2025)
  • K250946 — Denture Base Resin DT20 (March 31, 2025)