FDA.report

KULZER, LLC

Matched from indexed company URL: Kulzer, LLC

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
18215141821514KULZER, LLC1Y2026-01-014315 S. Lafayette Blvd. SOUTH BEND IN US 46614
96109023002807166KULZER GMBH1N2026-01-01PHILIPP-REIS-STRASSE 8/13 WEHRHEIM Hesse DE D-61273
30066108343006610834KULZER GMBH1N2026-01-01SchlatterstraBe 2 WASSERBURG Bavaria DE 88142
30054311693005431169KULZER DENTAL LTD.1N2020-04-25NO. 1585 GUMEI ROAD SHANGHAI Shanghai CN 200233

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
J014660164550Starlight pro - Glare shield, orange+1(800)431-1785customerservice.na@kulzer-dental.com
J014660573650Starlight pro - Light guide, 8mm, 70°+1(800)431-1785customerservice.na@kulzer-dental.com
J014660968300Starlight pro - 66096830+1(800)431-1785customerservice.na@kulzer-dental.com
J014660969290Starlight pro - Light guide, 8mm, 45°+1(800)431-1785customerservice.na@kulzer-dental.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
217671826956995K992985GLUMA COMFORT BONDKLE1999-10-14
217641826956995K992985GLUMA COMFORT BONDKLE1999-10-14
217641613785358K964038CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FGKLE1997-04-02
217641572956305K932013CHARISMA -- MODIFIEDEBF1993-07-08
217671667377445K924024ORTHO WAXEGD1992-11-17
217641504522101K915355ADS-GEL AND INSULATING-GELEBF1992-01-31
217671938367875K905058PALAVIT LEBH1991-06-06
217641234214422K902115PALAPRESS(R) VARIO RESINEBI1990-07-27
217641689036405K901789PALADON(R) 65EBI1990-06-22
217671627989830K812805STEELE'S ECON. PINK BASEPL. WAXES, I-IIIEGD1982-01-12
217641686130312K811669DURAFILL MICROFILL RESTORATIVE MATERIALEBF1981-07-01
217671694403854K254063iCEM Universal PlusEMA2025-12-19
217641643870380K123278IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELFKLE2012-12-07
217641670500387K110037PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUIDEBI2011-04-29
217641528196628K093575GLUMA DESENSITIZER POWER GELLBH2010-03-05
217641890882320K091635VENUS DIAMOND FLOWEBF2009-09-03
217681087692440K033628ARTICELM2004-01-16
217691078036222K011130PREMIUMELM2001-07-05
217681331206975K000213JELDENT BASIC LINEELM2000-04-06
217641024364690
217671151283396
217671275582386
217671287542746
217681536854034
217671739272617
217672054734968
217671005912318
217641029727927
217641070879774
217691087692440
217671093986262
217671115505824
217671175321424
217641191598609
217641313472975
217641330717674
217641368815511
217641399488089
217671409901746
217641495212086
217641523942429
217691536854034
217641609469716
217641614357463
217641685180970
217641687301831
217641766750085
217641767756385
217671772234176
217641798211891
217641811017742
217641824092239
217671847773551
217641853985803
217671859035480
217641890882320
217641896412892
217641941228033
217691977111193
217642053837915

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
KLE42012-12-07
EBF42009-09-03
EBI32011-04-29
ELM32004-01-16
EGD21992-11-17
EMA12025-12-19
LBH12010-03-05
EBH11991-06-06

PMN

GUDID

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