FDA.reportPublic FDA data

SMS OPCO, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30088826893008882689SMS OPCO, LLC1N2020-04-256270 Morning Star Drive Ste 120 The Colony TX US 75056

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1641061513623285K973776REFLECTIONSDYW1997-11-21
1641061268870374K895523PHASE II ORTHODONTIC ADHESIVEDYH1989-12-08
1641061283815841K895522LIGHT BOND PASTE W/FLUORIDEDYH1989-12-07
1641061756267218K875142PHASE IIDYH1988-02-29
1641061651271622K173785Custom Clear Aligner SystemNXC2018-03-13
1641061571886740K140807COMPOSITE ORTHODONTIC BRACKETSDYW2014-11-12
1641061179883391K131734ALL-BOND UNIVERSAL SC (NOT FINALIZED)KLE2014-04-11
1641061737785294K121093D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000EBZ2012-11-27
1641061191210574K083051FLOWTAIN & FLOWTAIN LVDYH2009-02-20
1641061903385257K071688RELIANCE S.E.P.KLE2007-09-07
1641061945016968K071590THERMA-CUREDYH2007-07-31
1641061355861688K063593CLEARFIL MAJESTY FLOWEBF2007-02-02
1641061398474446K053103INTERFACEKLE2006-02-01
1641061007314421
1641061057061158
1641061084599840
1641061121468257
1641061143215238
1641061307713779
1641061466752520
1641061480688213
1641061554639500
1641061562618760
1641061595839724
1641061646614125
1641061693524068
1641061767874259
1641061975538158

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DYH52009-02-20
KLE32014-04-11
DYW22014-11-12
NXC12018-03-13
EBZ12012-11-27
EBF12007-02-02

PMN#