Bright Bond Universal— 510(k) K200153

Substantially Equivalent

Genoss Co., Ltd.

FDA 510(k) clearance K200153 for Bright Bond Universal, Substantially Equivalent on 2020-10-28. Applicant: Genoss Co., Ltd.. Device class: 2.

Clearance details

Applicant: Genoss Co., Ltd.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2020-01-22
Decision date: 2020-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLE

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K252450 — Adhese 22026-03-05
K260682 — Bond-PR Universal Adhesive2026-03-03
K251587 — VITA VMLC Primer2026-02-23

More clearances from Genoss Co., Ltd.

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K232174 — rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono2024-02-23
K231480 — Bright MTA Sealer Plus2023-07-28

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