BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855— 510(k) K060646

Name: FDA 510(k) clearance K060646
Creator: U.S. Food and Drug Administration
Published: 2006-04-21

Substantially Equivalent

Monitex Industrial Co., Ltd.

FDA 510(k) clearance K060646 for BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855, Substantially Equivalent on 2006-04-21. Applicant: Monitex Industrial Co., Ltd.. Device class: 2.

Clearance details

Applicant: Monitex Industrial Co., Ltd.
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 2006-03-10
Decision date: 2006-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin-Chu City, TW

Download summary PDF View on FDA.gov ↗

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Recalls naming K060646

K-number listed on FDA's recall record

Z-0797-2019 — Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY.Class II·Ongoing·Handpiece Headquarters·20180404

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060646.

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