FDA.reportPublic FDA data

Ultradent Products Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
17189121718912Ultradent Products Inc.1Y2026-01-01505 W Ultradent Dr (10200 South) South Jordan UT US 84095

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
36111372736525K994261ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENTEMA2000-02-02
36111688310047K993846ULTRASEAL XT PLUSEBC2000-02-16
36111151016591K981596ULTRAPAK EMVL1998-07-31
36111002824623K974413PERMAFLOEBF1998-02-02
36112028271766K974282VITALESCENCEEBF1998-01-29
36111390310551K972239ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTINGELW1997-08-01
36111391383031K972027ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)ELW1997-07-16
36111736472244K971284OPALDAMEIG1997-06-03
36111905435834K970114ULTRACAL XSEJK1997-03-14
36111590318145K970113ULTRA-BLEND PLUSEJK1997-04-02
36111356776641K964808SPETEMPEMA1997-02-26
36111955957280K963979ULTRADENT UNIVERSAL DENTIN SEALANTLBH1996-12-12
36111086874305K960696PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEMKLE1996-07-18
36111265272595K953526SEEKLFC1995-09-05
36111143211493K951867PERMAQUIK BONDING PRIMERKLE1995-05-23
36111546305225K951583PERMAQUIK BONDING PRIMERKLE1995-05-12
36111433545322K951582ULTRADENT PORCELAIN ETCHEIH1995-05-10
36111592272638K950859PERMASEALEBF1995-03-23
36111922016212K941065DEOX, OXYGEN BARRIER VISCOUS SOLUTIONEMA1994-06-16
36111974509465K940860CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALSELW1994-05-27
36111170653812K934415FILE-EZEKJJ1994-04-13
36111909329030K931868PRIMADRY PRODUCT LINEEBC1993-07-22
36111871468974K931867ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINEEBF1993-09-09
36111535103274K925375CONSEPSIS SCRUBLBH1993-07-22
36111382371226K924982CONSEPSIS(TM)LBH1993-07-08
36111527028567K921601ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINEJES1992-06-16
36111213669397K921409ENAMEL AND PORCELAIN ETCH PRODUCT LINEEBF1992-09-09
36111595345233K921407COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINEEBF1992-09-09
36111510735355K913537MEMOSIL C.D.ELW1991-10-04
36111888397147K262228Transcend Bulk Fill Flowable CompositeEBF2026-07-01
36112045778109K261404UltraEZLBH2026-04-30
36111573228964K240694FORMA Composite (Shade A3D)EBF2024-03-15
36111677263859K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioEBC2023-08-18
36111966832925K221909J-TempEBF2022-07-01
36111108205919K220471VALO X, VALO X Accessory LensesEBZ2022-02-22
36111515557002K211905UltraCal XSKIF2021-10-13
36111412829120K211531Cordless Prophy System, Model: i-PolishEKX2021-12-17
36111070595141K211237UltraTemp Rez IIEMA2021-07-13
36111012715792K210550VALO Grand Corded and Accessory LensesEBZ2021-03-01
36111876810229K201795TranscendEBF2020-09-28
36111196108860K190627VALO Grand CordedEBZ2019-04-29
36112070859948K181917MTA2.3 MATERIALSKIF2019-01-11
36112006780078K173163ChlorCid, ChlorCid V, ChlorCid SurfKJJ2018-02-09
36111630395349K161239MTA2.2 MATERIALKIF2016-09-01
36111726234498K160551VALO GrandEBZ2016-07-13
36112063400506K151123Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier FilmPEM2016-03-03
36111649749131K151094Mosaic Universal CompositeEBF2015-07-21
36111346968958K132953TIDISHEILDPEM2014-02-18
36111875402550K132255ULTRACEMEMA2013-10-24
36111935686762K132109ENAMELASTLBH2013-11-01
36111817110848K131357PEAK ZKLE2013-09-06
36111717833249K123215VISCOSTAT CLEARMVL2013-02-05
36111689043250K122892MTA2 ROOT AND PULP MATERIALSKIF2012-12-11
36111307161988K122039KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS BEBG2012-12-27
36111958618560K112517ULTRASEAL XT HYDROEBC2011-09-23
36111148529435K111836PERMASHADE VENEER CEMENTEMA2011-09-16
36111784457011K111696OPAL BAND CEMENTDYH2011-09-07
36111989298815K111017CLEARTEMPEMA2011-06-06
36111405225928K110582VALO CORDLESSEBZ2011-04-28
36112065767019K102739HYDROCOLOR 5ELW2010-12-08
36111397947637K100752PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)KLE2010-07-16
36111956649787K100301OPAL BOND FLOWDYH2010-04-29
36111384862609K094006OPAL BOND MVDYH2010-03-23
36111199715326K090355OPAL SEALDYH2009-04-29
36111996822016K083701PANASIL INITIAL CONTACT AND PANASIL TRAYELW2009-01-09
36111719148790K083647VALO, MODEL 5919EBZ2009-01-23
36111661031933K082560PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACTELW2008-09-08
36111922147291K082157KETTOSIL AND SILGINATELW2008-08-06
36111028206788K081120FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALSELW2008-05-01
36111013556156K080768ULTRATEMP FIRM, FAST AND REGULAR SETEMA2008-04-11
36112057216040K071106ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399KIF2007-05-08
36111722889451K071055OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802DYW2007-05-03
36111859233402K070155INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNCEFB2007-01-25
36111848017168K063703CITRIC ACID 20% SOLUTION, MODEL 329KJJ2006-12-21
36111466664619K063558PEAK SE, MODEL 5135KLE2006-12-14
36111765668239K061438ULTRAEZ DESENSITIZING GELLBH2007-06-12
36111015322198K060335FILE-EZEKJJ2006-02-24
36111684372368K052741IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIESEBW2006-01-13
36111349102232K050895SURPASSON P5 NEWTRONELC2005-04-20
36111256512905K043119AMELOGEN PLUSEBF2004-12-17
36111019560005K043118HYDROGUM SOFTELW2005-01-24
36111672541578K024034OCCLUFAST ROCKELW2002-12-18
36111576116143K023042PQ1KLE2002-10-28
36111344363270
36111373258456
36111572084215
36111802953686
36111805950711
36111932717312
36111980590822
36112029513550
36111040690046
36111058649538
36111204964282
36111211687234
36111216199450
36111307576799
36111363037743
36111404676130
36111585923125
36111612472136
36111640909979
36111702345850
36111706052934
36111716291561
36111728476928
36111736539324
36111772857126
36111778340355
36111779757108
36111795979637
36111952455086
36111979561005
36112073192000

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBF122026-07-01
ELW112010-12-08
EMA82021-07-13
KLE72013-09-06
LBH62026-04-30
EBZ62022-02-22
KIF52021-10-13
EBC42023-08-18
KJJ42018-02-09
DYH42011-09-07
PEM22016-03-03
MVL22013-02-05
EJK21997-04-02
EKX12021-12-17
EBG12012-12-27
DYW12007-05-03
EFB12007-01-25
EBW12006-01-13
ELC12005-04-20
EIG11997-06-03
LFC11995-09-05
EIH11995-05-10
JES11992-06-16