FDA.reportPublic FDA data

Handpiece Headquarters

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30070073573007007357Handpiece Headquarters1Y2026-01-01620 S. Placentia Ave. Placentia CA US 92870

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1007942032209861K243911HPR Cordless Hygiene HandpieceEKX2024-12-20
1007941977703908K233518BASE290 LED Curing LightEBZ2023-11-02
1007941918427015K221955Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20MUH2022-08-31
1007941245846377K180845Maxima Electric SystemEBW2019-07-25
1007942018146116K143183Maxima XTEND Handpiece Maintenance SystemEFB2015-02-17
1007941282753387K141125U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLEEGS2014-10-23
1007941187863673K113674SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANTEFB2012-04-05
1007942006883395K100389HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENTEFB2010-08-12
1007941827828792K092053MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATHEGS2009-08-20
1007941968518736K080682HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECEEFB2008-09-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EFB72015-02-17
EGS32014-10-23
EBW22019-07-25
EKX12024-12-20
EBZ12023-11-02
MUH12022-08-31

PMN#