Instrumentarium Dental, Palodex Group OY

Instrumentarium Dental, Palodex Group OY holds 5 FDA 510(k) medical device clearances, first cleared 2007, most recent 2014, with 1 FDA device recall on record.

Top product codes for Instrumentarium Dental, Palodex Group OY

MUH — Dental5 devices

FDA recalls by Instrumentarium Dental, Palodex Group OY

Z-1091-2014 — The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which reads the image data from a sensor and displays the image on the PC monitor. In order to make installation and service faster and easier the electronics is integrated into the horizontal arm. FOCUS is intended to be used for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.Class II·Terminated·2014-01-14

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

Recent clearances by Instrumentarium Dental, Palodex Group OY

K133231 — DIGORA OPTIMECode MUH·2014-03-20
K093683 — ORTHOPANTOMOGRAPH OP300Code MUH·2010-10-06
K092591 — ORTHOPANTOMOGRAPH OP30Code MUH·2009-11-20
K081925 — SNAPSHOTCode MUH·2008-09-02
K063837 — SIGMA MCode MUH·2007-07-02

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