FDA.reportPublic FDA data

KULZER GMBH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96109023002807166KULZER GMBH1N2026-01-01PHILIPP-REIS-STRASSE 8/13 WEHRHEIM Hesse DE D-61273
30066108343006610834KULZER GMBH1N2026-01-01SchlatterstraBe 2 WASSERBURG Bavaria DE 88142

GUDID Contact Samples#

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

Source GUDID, Product, Phone table
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 key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
217641826956995K992985GLUMA COMFORT BONDKLE1999-10-14
217641613785358K964038CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FGKLE1997-04-02
217641572956305K932013CHARISMA -- MODIFIEDEBF1993-07-08
217641504522101K915355ADS-GEL AND INSULATING-GELEBF1992-01-31
217641234214422K902115PALAPRESS(R) VARIO RESINEBI1990-07-27
217641689036405K901789PALADON(R) 65EBI1990-06-22
217641686130312K811669DURAFILL MICROFILL RESTORATIVE MATERIALEBF1981-07-01
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
217691078036222K011130PREMIUMELM2001-07-05
217641024364690
217641029727927
217641070879774
217691087692440
217641191598609
217641313472975
217641330717674
217641368815511
217641399488089
217641495212086
217641523942429
217691536854034
217641609469716
217641614357463
217641685180970
217641687301831
217641766750085
217641767756385
217641798211891
217641811017742
217641824092239
217641853985803
217641890882320
217641896412892
217641941228033
217691977111193
217642053837915

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBF42009-09-03
KLE32012-12-07
EBI32011-04-29
LBH12010-03-05
ELM12001-07-05

GUDID#

200 records. Showing 1-40. Next