Delight, Delight ortho, B&Lite S— 510(k) K170529

Name: FDA 510(k) clearance K170529
Creator: U.S. Food and Drug Administration
Published: 2017-08-08

Substantially Equivalent

Dentall Co., Ltd.

FDA 510(k) clearance K170529 for Delight, Delight ortho, B&Lite S, Substantially Equivalent on 2017-08-08. Applicant: Dentall Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dentall Co., Ltd.
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 2017-02-22
Decision date: 2017-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bucheon-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBZ

view all

K253131 — Curing Light (M-Cure 6)2026-06-18
K253461 — Demi Pro2025-10-14
K242386 — Bluemoon2025-05-05
K243921 — LED Curing Lights (DB686 HALO)2025-04-11
K250009 — LED Curing Light (C01-X, C02-X)2025-04-10

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