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Heraeus Kulzer, Inc.

145 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
FLEXITIME FLOW (K091494)Heraeus Kulzer, Inc.2009-07-31
HKBOND 2006 (K063062)Heraeus Kulzer, Inc.2006-12-01
MONDIAL (K060994)Heraeus Kulzer, Inc.2006-05-22
HERACERAM ZIRKONIA (K052543)Heraeus Kulzer, Inc.2005-10-25
PALAIMPACT (K043504)Heraeus Kulzer, Inc.2005-01-28
VERSYO.DIRECT (K043295)Heraeus Kulzer, Inc.2005-01-05
FLEXITIME XTREME (K042878)Heraeus Kulzer, Inc.2004-12-17
OSTIM (K030052)Heraeus Kulzer, Inc.2004-12-06
HERACERAM PRESS (K040859)Heraeus Kulzer, Inc.2004-05-20
NDX-40 ALLOY (K040043)Heraeus Kulzer, Inc.2004-03-03
ARTIC (K033628)Heraeus Kulzer, Inc.2004-01-16
VENUS FLOW (K033665)Heraeus Kulzer, Inc.2003-12-30
VERSYO.BOND (K033629)Heraeus Kulzer, Inc.2003-12-22
P2 POLYETHER (K030318)Heraeus Kulzer, Inc.2003-04-03
IBOND GLUMA INSIDE (K022612)Heraeus Kulzer, Inc.2002-10-28
VENUS UNIVERSAL LIGHT CURING COMPOSITE (K020131)Heraeus Kulzer, Inc.2002-02-28
TRANSLUX ENERGY (K012341)Heraeus Kulzer, Inc.2001-08-30
PREVISION CHEM (K010541)Heraeus Kulzer, Inc.2001-07-31
PREMIUM (K011130)Heraeus Kulzer, Inc.2001-07-05
VERSYO.COM (K010800)Heraeus Kulzer, Inc.2001-05-31
RD-3008 (K011036)Heraeus Kulzer, Inc.2001-05-10
FLEXTIME MAGNUM 360 (K003930)Heraeus Kulzer, Inc.2001-02-01
FLEXTIME (K000629)Heraeus Kulzer, Inc.2000-04-05
SOLITAIRE 2 (K993932)Heraeus Kulzer, Inc.1999-12-22
PRE-VISION FILL (K993602)Heraeus Kulzer, Inc.1999-12-15
GLUMA COMFORT BOND (K992985)Heraeus Kulzer, Inc.1999-10-14
GLUMA COMFORT BOND + DESENSITIZER (K992292)Heraeus Kulzer, Inc.1999-10-01
XANTOPREN COMFORT (K991425)Heraeus Kulzer, Inc.1999-06-15
FLOW LINE (K990756)Heraeus Kulzer, Inc.1999-05-07
GLUMA ONE BOND (K990143)Heraeus Kulzer, Inc.1999-02-25
NTI CLENCHING SUPPRESSION SYSTEM (K981546)Heraeus Kulzer, Inc.1998-07-15
GLUMA ONE BOND (K974390)Heraeus Kulzer, Inc.1998-02-04
PROVIL NOVO (K973694)Heraeus Kulzer, Inc.1997-11-24
2 BOND 2 (K971733)Heraeus Kulzer, Inc.1997-10-02
SOLITAIRE (K972101)Heraeus Kulzer, Inc.1997-09-29
MEMOREG (K971155)Heraeus Kulzer, Inc.1997-05-22
SILOC SYSTEM (K970848)Heraeus Kulzer, Inc.1997-05-06
CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG (K964038)Heraeus Kulzer, Inc.1997-04-02
CUTTERSIL COMFORT (K965163)Heraeus Kulzer, Inc.1997-03-19
CUTTERSIL COMFORT HARDENER (K965165)Heraeus Kulzer, Inc.1997-03-19
GLUMA CONDITIONER (K964140)Heraeus Kulzer, Inc.1996-11-05
GLUMA DESENSITIZER/GLUMA 3 PRIMER (K962812)Heraeus Kulzer, Inc.1996-10-07
QUICKSPLINT (K961995)Heraeus Kulzer, Inc.1996-06-26
CHARISMA SINGLE DOSE (K954929)Heraeus Kulzer, Inc.1995-11-27
PALASPLINT (K953743)Heraeus Kulzer, Inc.1995-10-02
ARTGLASS & KEVLOC (K954115)Heraeus Kulzer, Inc.1995-09-27
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION (K951058)Heraeus Kulzer, Inc.1995-06-01
DCA 2000 SYSTEM FOR HEMOGLOBIN A1C (K951361)Heraeus Kulzer, Inc.1995-05-05
CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER (K946183)Heraeus Kulzer, Inc.1995-02-22
NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS) (K943780)Heraeus Kulzer, Inc.1994-10-31
AMES DCA 2000 HEMOGLOBIN ALC CONTROLS (K940971)Heraeus Kulzer, Inc.1994-07-19
GLUCOMETER ELITE LOW CONTROL (K940577)Heraeus Kulzer, Inc.1994-06-13
GLUCOFILM TEST STRIPS (K936212)Heraeus Kulzer, Inc.1994-05-10
DENTACOLOR VITA (VS) SHADE SYSTEM (K940800)Heraeus Kulzer, Inc.1994-04-07
ATTACHMENT BOND (K935735)Heraeus Kulzer, Inc.1994-03-07
CHARISMA SUPERLIGHT (K935736)Heraeus Kulzer, Inc.1994-01-26
IMPAX 5000 (K934386)Heraeus Kulzer, Inc.1994-01-05
IMPAX 3000 (K934832)Heraeus Kulzer, Inc.1993-12-14
DENTALON PLUS MODIFICATION (K934283)Heraeus Kulzer, Inc.1993-12-10
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION (K934900)Heraeus Kulzer, Inc.1993-12-07
GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION (K934898)Heraeus Kulzer, Inc.1993-12-07
GLUCOSTIX REAGENT STRIPS (K926362)Heraeus Kulzer, Inc.1993-11-10
FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R) (K930322)Heraeus Kulzer, Inc.1993-11-10
IMPAX 1000 (K933409)Heraeus Kulzer, Inc.1993-11-03
GLUCOFILM TEST STRIPS (K926360)Heraeus Kulzer, Inc.1993-09-08
PALAVIT 55 AND DENTACOLOR CONNECTOR (K932034)Heraeus Kulzer, Inc.1993-08-06
MATRIX CCM 600 (K926009)Heraeus Kulzer, Inc.1993-07-20
DENTHESIVE II (K931838)Heraeus Kulzer, Inc.1993-07-08
CHARISMA -- MODIFIED (K932013)Heraeus Kulzer, Inc.1993-07-08
GLUCOMETER M+ BLOOD GLUCOSE METER (K931310)Heraeus Kulzer, Inc.1993-06-25
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER (K926361)Heraeus Kulzer, Inc.1993-06-24
TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.) (K930685)Heraeus Kulzer, Inc.1993-06-22
PALATRAY LC MINT (K930487)Heraeus Kulzer, Inc.1993-06-18
PMI100 VIDEO IMAGER (K925220)Heraeus Kulzer, Inc.1993-05-20
CHEK-STIX CONTROL STRIPS FOR URINALYSIS (K931467)Heraeus Kulzer, Inc.1993-05-11
TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM) (K930148)Heraeus Kulzer, Inc.1993-05-11
CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO (K930208)Heraeus Kulzer, Inc.1993-04-20
MATRIX CR 2050, PMI 3000 (K925289)Heraeus Kulzer, Inc.1993-04-08
CLINITEK 200+ URINE CHEMISTRY ANALYZER (K926359)Heraeus Kulzer, Inc.1993-01-28
URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS (K926144)Heraeus Kulzer, Inc.1993-01-27
ELITE TEST STRIPS GLUCOMETER (K924499)Heraeus Kulzer, Inc.1992-12-17
TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1 (K925203)Heraeus Kulzer, Inc.1992-11-25
ORTHO WAX (K924024)Heraeus Kulzer, Inc.1992-11-17
PALABOND (K924422)Heraeus Kulzer, Inc.1992-11-04
TECHNICON DAX SYSTEM THYROXINE (T4) METHOD (K922945)Heraeus Kulzer, Inc.1992-10-14
PALADISC LC (K923549)Heraeus Kulzer, Inc.1992-09-29
MILES URINE AMYLASE METHOD (K923105)Heraeus Kulzer, Inc.1992-09-28
ENCORE TEST STRIPS (K923018)Heraeus Kulzer, Inc.1992-09-23
TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE (K923258)Heraeus Kulzer, Inc.1992-09-23
MILES AUTO METH DETERMIN OF URIC ACID IN URINE (K924129)Heraeus Kulzer, Inc.1992-09-22
MILES SODIUM METHOD (K923037)Heraeus Kulzer, Inc.1992-09-22
PALADUR (K915898)Heraeus Kulzer, Inc.1992-09-16
MILES URINE GLUCOSE METHOD (K923040)Heraeus Kulzer, Inc.1992-09-15
MILES URINE CALCIUM METHOD (K923034)Heraeus Kulzer, Inc.1992-09-15
TECHNICON H*2 (K923237)Heraeus Kulzer, Inc.1992-09-11
MILES URINE UREA NITROGEN METHOD (K923035)Heraeus Kulzer, Inc.1992-09-09
URINE CHLORIDE (K923036)Heraeus Kulzer, Inc.1992-09-09
MILES POTASSIUM METHOD (K923038)Heraeus Kulzer, Inc.1992-08-24
MILES URINE CREATININE METHOD (K923039)Heraeus Kulzer, Inc.1992-08-24
SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR) (K921939)Heraeus Kulzer, Inc.1992-07-16
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