TERA HARZ II— 510(k) K233502

Substantially Equivalent

Graphy, Inc.

FDA 510(k) clearance K233502 for TERA HARZ II, Substantially Equivalent on 2023-11-01. Applicant: Graphy, Inc.. Device class: 2.

Clearance details

Applicant: Graphy, Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2023-10-31
Decision date: 2023-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

K262202 — Cerasmart Forte2026-09-10
K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)2026-08-31
K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

More clearances from Graphy, Inc.

K253681 — TERA HARZ Hard Denture (8 models)2025-11-21
K240597 — TERA HARZ CLEAR2024-03-05
K223355 — Tera Harz Clear2022-11-03
K222414 — TERA HARZ DENTURE2022-08-11
K202846 — TERA HARZ2021-07-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.