FDA.reportPublic FDA data

SPOFADENTAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30077438833007743883SpofaDental a.s.1N2026-01-01Markova 238 Jicin Hradec Kralove CZ 506 01

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1050331854747207K955932EXAFLEX IMPRESSION MATERIAL (MODIFICATION)ELW1996-03-11
1050331910254281K810825POLYVINYL SILICONE IMPRESSION MATERIALELW1981-04-14
1050332054783823K160441Identic and KromaFaze Alginate Dental Impression MaterialsELW2016-06-30
1050331426583903K160097Image Fast Set, Image Regular SetELW2016-08-05
1050331253656324K123595NEXUS RMGIEMA2013-02-19
1050331255160142K110378IMPRESSION COMPOUNDELW2011-04-05
1050331022243187
1050331175718961
1050331253098455
1050331272172300
1050331285729267
1050331327524489
1050331331734303
1050331361284124
1050331428213601
1050331660439465
1050331747684087
1050331822647216
1050331950341580
1050332007311985
1050332057442261

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ELW52016-08-05
EMA12013-02-19

PMN#