FDA.reportPublic FDA data

DENTSPLY DETREY GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80106383004724816DENTSPLY DETREY GmbH1N2026-01-01DETREY STRASSE 1 KONSTANZ Baden-Wurttemberg DE 78467

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
75711513539030K960548AH PLUS ROOT CANAL SEALERKIF1996-04-26
75711433626538K780301CAULK TYLOKEMA1978-02-28
75711572531196K243546AH Plus Endodontic SealerKIF2025-02-13
75711221393879K192530Surefil one Self-adhesive Composite HybridEMA2020-01-23
75711329701157K182288TPH Spectra ST Flowable Composite RestorativeEBF2018-11-20
75711681928319K181476Prime&Bond active Universal AdhesiveKLE2018-09-28
75711427916466K162107TPH Spectra+ Universal Composite RestorativeEBF2016-09-27
75711224505457K160232Disposable Barrier Sleeves and CoversPEM2016-06-07
75711562040749K101493ADVANCED GLASS IONOMER (K-130) RESTORATIVEEMA2010-08-19
75711599459560K070538XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVEKLE2007-03-14
75711330118694K052097CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVEEBF2005-08-12
75711958564735K050880DYRACT EXTRA RESTORATIVEEBF2005-04-22
75711124019371K041372SMARTLITE PS PEN-STYLE LED CURING LIGHTEBZ2004-06-24
75711037061205K040144QUIXX POSTERIOR RESTORATIVEEBF2004-04-01
75711326935191K023776XENO III DENTAL ADHESIVEKLE2003-01-23
75711044837115
75711193864441
75711229923930
75711389921053
75711421704517
75711605838732
75711731352728

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBF52018-11-20
KLE42018-09-28
EMA32020-01-23
KIF22025-02-13
PEM12016-06-07
EBZ12004-06-24