FDA.reportPublic FDA data

DENTSPLY NORTH AMERICA LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30061867963006186796DENTSPLY NORTH AMERICA LLC1Y2026-01-011800 Cloister Drive Lancaster PA US 17601
30145367603014536760Dentsply North America LLC1Y2026-01-0113320B Ballantyne Corporate PL. Charlotte NC US 28277

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
75621633448648K963205ALGINMAX, ORTHOCHROMEELW1996-10-29
75621930468652K924211EJECTORDYN1993-03-31
75621167972067K922499REFLECTIONS - CERAMIC DENTAL BRACKETEJF1992-07-30
75621068849943K902836MICROETCHERKOJ1990-11-20
75622057750307K895521RELY-A-BOND W/FLUORIDE (NO MIX ADHESIVE)DYH1989-12-07
75621540458723K882482TRIAD ORTHODONTIC GELEBI1988-08-12
75621807952126K191865SmartLite Pro Modular LED Curing LightEBZ2019-11-20
75621071793964K160615ORTHODONTIC CERAMIC BRACKETS 1.1NJM2016-08-26
75621462096846K123925MTM CLEAR ALIGNER IN-OFFICENXC2013-05-24
75621162333147K123092CERAMIN BRACKETS ZNJM2012-12-21
75621376667990K113401ORTHO-1(NOT FINALIZED)DYH2012-02-07
75621873968171K092030ELATION MB METAL REINFORCED PLASTIC BRACKETDYW2009-07-24
75621072067026K090454ALLURE MB CERAMIC BRACKETSNJM2009-03-20
75621657933684K082974MYSTIQUE MB CERAMIC BRACKETSNJM2008-11-07
75621179134678K080906CDB CLIPNJM2008-10-17
75621676516868K080246COMPOSITE ALIGNER BUTTONNXC2008-04-11
75622011224129K062400IMPRESSIX, COLORCHANGE ALGINATEELW2006-11-16
75621044110349K053368INTERPROXIMAL REDUCTION SYSTEMEFB2006-03-29
75621482494235K053055ORTHODONTIC POLYMER COMPOSITE BRACKETDYW2005-12-22
75621234286133K052455IMPRESSIXELW2005-11-23
75621133310261K052370CP BRACKET SYSTEMDYW2005-11-01
75621625807600K040375IDEAL 1 ORTHODONTIC BAND CEMENTDYH2004-04-02
75621532781311K001108PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIALEBF2000-05-30
75621431981658K000358MULTI ADJUSTABLE FACE MASKDZB2000-06-09
75621038047394
75621069978970
75621140794781
75621147812230
75621214451657
75621235463921
75621252218706
75621259858292
75621265198837
75621272750400
75621326033461
75621340007421
75621347116199
75621349050331
75621386001033
75621389921053
75621406337521
75621438566132
75621445235455
75621489927009
75621551896334
75621586449835
75621624532138
75621646775811
75621646795082
75621666254191
75621675418930
75621678722230
75621681979061
75621691666886
75621701301465
75621704729770
75621731352728
75621776896318
75621813355425
75621840003839
75621840288821
75621884390830
75621912518887
75621936570130
75621959683304
75621969505735
75622008077674
75622018329748
75621016583361
75621028423531
75621324931125
75621674301878
75621869599463
75621943067720
75621997550791

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NJM52016-08-26
DYH32012-02-07
DYW32009-07-24
ELW32006-11-16
NXC22013-05-24
EBZ12019-11-20
EFB12006-03-29
DZB12000-06-09
EBF12000-05-30
DYN11993-03-31
EJF11992-07-30
KOJ11990-11-20
EBI11988-08-12