ClearanceBrief
Recall Z-0313-2007 ยท EFA Handpiece, Belt And/Or Gear Driven, Dental

Stardental Division

Solara Replacement Turbine, Autochuck End Cap, for dental handpiece, part number 064900.

DateDec 27, 2006 (initiated Dec 1, 2006)
StatusTerminated
ReasonEnd cap component can disassemble.
Root causeOther
ActionThe recalling firm sent recall letters to dealers and doctors via certified mail, return receipt on 12/6/06. Letters to the foreign accounts were sent via UPS or other traceable methods.
Quantity2756 end caps
DistributionWorldwide distribution, including USA, Canada and Japan.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K960507STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES
Dentalez Group, Mar 28, 1996
K960719STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE
Dentalez Group, Mar 28, 1996