Recall Z-0797-2019— Handpiece Headquarters

Name: FDA recall Z-0797-2019
Creator: U.S. Food and Drug Administration
Published: 2018-04-04

Class II · Ongoing

Class II FDA medical device recall by Handpiece Headquarters, initiated 2018-04-04. It names one FDA 510(k) clearance: K060646. Product: 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.. Reason: Tip of the curing light was too hot causing a heat sensation in the patients..

Recalling firm: Handpiece Headquarters
Classification: Class II
Status: Ongoing
Initiated: 2018-04-04
Firm location: Placentia, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K060646 — BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855Monitex Industrial Co., Ltd.·cleared 2006-04-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Tip of the curing light was too hot causing a heat sensation in the patients.

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