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510(k) K240597

TERA HARZ CLEAR by Graphy, Inc. — Product Code NXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2024
Date Received
March 4, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Aligner, Sequential
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type

The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.

Other clearances by Graphy, Inc.

  • K253681 — TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HA (November 21, 2025)
  • 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 NXC

  • K253282 — ZSmile System (February 3, 2026)
  • K251454 — Clear Aligner (SCF-3348) (January 7, 2026)
  • K250739 — Primeprint Direct Aligner (November 7, 2025)
  • K252931 — Invisalign® Palatal Expander System (October 23, 2025)
  • K252870 — Invisalign Specifix Attachment System (October 9, 2025)
  • K251758 — Serafin® (September 11, 2025)
  • K252380 — Invisalign System (August 29, 2025)
  • K251415 — Additively Manufactured Aligner Resin (August 27, 2025)
  • K251616 — Clear Miracle (July 22, 2025)
  • K242637 — MEM Clear Aligner System (May 21, 2025)