FDA.reportPublic FDA data

David Rothkopf

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30055198193005519819David Rothkopf1N2026-01-01200 Homer Ave Ashland MA US 01721
30059404003005940400David Rothkopf1N2026-01-01200 Homer Ave Ashland MA US 01721
30071651833007165183David Rothkopf1N2026-01-01200 Homer Avenue Ashland MA US 01721

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1298461013093297K903058BACT-HME (TM)BYD1990-11-09
1298461692057919K903056BACTTRAPCAH1990-11-05
1298461083441031K903054HME-10 (TM)BYD1990-10-31
1298461581163065K202459Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/FilterCAH2021-09-26
793241292601681K2022563Shape Implant StudioLLZ2020-09-09
793241609427151K200100Abutment DesignPNP2020-10-07
793241882360268K1919113Shape Splint DesignPNN2019-11-27
793241450102464K180941Ortho SystemPNN2018-10-17
793241729276841K171634Ortho SystemPNN2018-01-17
793241420933705K161884Ortho SystemMQC2017-04-19
793241339227374K1520863Shape Ortho SystemPNN2016-04-28
793241725480996K1514553Shape Abutment Designer SoftwarePNP2016-09-06
1298461082120592K093426BACT-TRAP HEPA MIDICAH2010-02-22
1298461608362202K090738THERMOFLO HCH, THERMOFLO FILTERCAH2009-07-27
926751707187691K081218BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICASTIYE2008-07-21
1298461555621922K011212FILTERFLO HCAH2001-12-20
793241035002055
793241361505827
793241558101016

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAH52021-09-26
PNN42019-11-27
PNP22020-10-07
IYE22008-07-21
BYD21990-11-09
LLZ12020-09-09
MQC12017-04-19