FDA.report

PRIMOTEC LLC

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30044910433004491043PRIMOTEC LLC1Y2026-01-01215 Westport Ave Norwalk CT US 06851

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1448601754447189K926070PRIMODENT ACRYLIC TEETHELM1994-02-17
1448601985417117K152175Upcera Dental Zirconia Blank for Aesthetic RestorationEIH2015-12-04
1448601687200145K151399Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq FlowEBF2016-10-24
1448601152694790K141724UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANKEIH2014-10-22
1448601424418663K141421PMMA BLOCKEBG2015-02-09
1448601099922612K102341VIPI BLOCKEBG2010-12-16
1448601778190440K101029KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETHELM2010-08-16
1448601565091812K030832PRIMOSPLINT SYSTEMMQC2003-09-17
1448601953917408K001041AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLDEJT2000-05-23
1448601018667457
1448601886106311

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
EIH22015-12-04
EBG22015-02-09
ELM22010-08-16
EBF12016-10-24
MQC12003-09-17
EJT12000-05-23

GUDID

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