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Planmeca USA, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K111361PLANMED NUANCE EXCELSeptember 23, 2011
K081699PLANMECA SOVEREIGNAugust 29, 2008
K923534PM2002 PROLINEJanuary 31, 1994
K923533ADMARKMarch 4, 1993
K923461PM2002 PROLINE, PM2002 PROLINE ECDecember 21, 1992
K923462DELIGHTDecember 21, 1992
K904953PLANMED SOPHIEApril 18, 1991
K904948PM2002 CC AND PM2002 ECJanuary 30, 1991
K904947PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXEJanuary 30, 1991
K864474DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMICNovember 26, 1986
K842359AUTOMATIC PATIENT CHAIR PM2000 & ASeptember 19, 1984
K842357PM 2000 DENTAL UNITSeptember 12, 1984
K842358ISOLIGHTJuly 31, 1984