Bright MTA Sealer Plus— 510(k) K231480

Substantially Equivalent

Genoss Co., Ltd.

FDA 510(k) clearance K231480 for Bright MTA Sealer Plus, Substantially Equivalent on 2023-07-28. Applicant: Genoss Co., Ltd.. Device class: 2.

Clearance details

Applicant: Genoss Co., Ltd.
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2023-05-22
Decision date: 2023-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIF

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K253909 — NeoPEX Pre-Mixed Obturation Paste2026-09-04
K261514 — Calcium Hydroxide Temporary Filling Material (KP-Cal)2026-08-25
K261415 — Injectable Root Canal Sealer (KP-Root SP)2026-06-29
K253167 — Any-Paste2026-01-12

More clearances from Genoss Co., Ltd.

K242386 — Bluemoon2025-05-05
K222688 — The Trust2024-08-09
K233885 — rainbow Paste Stain SE2024-06-21
K232174 — rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono2024-02-23
K214086 — Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty2022-12-15

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