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510(k) K233502

TERA HARZ II by Graphy, Inc. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2023
Date Received
October 31, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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)
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  • K223355 — Tera Harz Clear (November 3, 2022)
  • K222414 — TERA HARZ DENTURE (August 11, 2022)
  • K202846 — TERA HARZ (July 15, 2021)

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