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Dental

12,644 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
HERACERAM 75 (K010416)Jelenko Co.2001-03-08
D.SIGN 30 (K010381)Ivoclar North America, Inc.2001-03-06
TAKE 1 (K003808)Sybron Dental Specialties, Inc.2001-03-01
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM (K010320)Depuyacromed2001-03-01
TETRIC CERAM HB (K010250)Ivoclar North America, Inc.2001-02-28
DUO-DENT DENTAL IMPLANT (K010386)Duo-Dent Dental Implant Systems, LLC2001-02-27
SMF RESORBABLE MESHES AND SHEETS (K003786)Synthes (Usa)2001-02-27
PALFIQUE ESTELITE LV CLEAR (K010267)Tokuyama America, Inc.2001-02-27
MINIENDO III (K003640)Sybron Dental Specialties, Inc.2001-02-22
CHALLENGER DIRECT COMPOSITE (K010219)International Dental Research2001-02-21
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS (K003549)Codman & Shurtleff, Inc.2001-02-15
PERMLASTIC 3 (K003650)Sybron Dental Specialties, Inc.2001-02-15
DURABOND NON-PRECIOUS CERAMIC ALLOY (K010069)Matech, Inc.2001-02-15
BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED, 3.308, 3.310,3.312, 3.314 3.316 (K010343)Buck Medical Research2001-02-14
LC PROVIFILL (K010012)S & C Polymer GmbH2001-02-14
SERENOCEM, MODEL BC 010 (K003567)Corinthian Medical , Ltd.2001-02-12
LORENZ RESORBABLE DISTRACTOR SYSTEM (K002083)Walter Lorenz Surgical, Inc.2001-02-12
COSMIC (K010044)Jeneric/Pentron, Inc.2001-02-09
3I CALCIUM SODIUM PHOSPHATE BONE CEMENT (K003493)Biomet, Inc.2001-02-09
THERMOFX MESH (K003757)Bionx Implants, Ltd.2001-02-07
IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) (K002469)W&H Dentalwerk Buermoos GmbH2001-02-07
PALMLIGHT (K003383)Ultradent Products, Inc.2001-02-06
EXCITE DSC (K003293)Ivoclar North America, Inc.2001-02-06
ACE SDS 3.75MM SCREW DENTAL IMPLANT (K002075)Ace Surgical Supply Co., Inc.2001-02-02
OCO DENTAL IMPLANT (K010142)O Co., Inc.2001-02-01
PROCLUDE-SENSITIVE (K003482)Ortek Therapeutics, Inc.2001-02-01
FLEXTIME MAGNUM 360 (K003930)Heraeus Kulzer, Inc.2001-02-01
THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY (K002426)Bioplate, Inc.2001-01-26
SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) (K003407)Ivoclar North America, Inc.2001-01-26
ZINC PHOSPHATE CEMENT (K003427)Rite-Dent Manufacturing Corp.2001-01-24
THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE (K994060)Bioplate, Inc.2001-01-24
DYRACT CEM LCI COMPOMER (K003921)Dentsply Intl.2001-01-24
ALGINATE IMPRESSION MATERIAL (K003426)Rite-Dent Manufacturing Corp.2001-01-23
CAVEX TEMPORARY CEMENT (K003791)Cavex Holland BV2001-01-23
MOLINA ORBITAL MALAR DISTRACTOR (K003883)KLS-Martin L.P.2001-01-23
SPLINE DENTAL IMPLANT SYSTEM (K010073)Sulzer Calcitek, Inc.2001-01-19
SYMPHONY GRAFT DELIVERY SYSTEM (K003286)Depuyacromed2001-01-18
MAXILLARY DISTRACTOR (K003393)Synthes (Usa)2001-01-17
PATTERN RESIN (K003817)GC America, Inc.2001-01-16
THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM (K003226)Lifecore Biomedical, Inc.2001-01-12
2-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYSTEM (K001259)Basic Dental Implant Systems, Inc.2001-01-12
AVANTE CURELIGHT (K003683)Jeneric/Pentron, Inc.2001-01-11
BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE (K003603)Jelenko Co.2001-01-10
AUROFILM NP (K003387)Metalor Dental USA Corp.2001-01-09
SYNTHES (USA) RESORBABLE TACK SYSTEM (K000560)Synthes (Usa)2001-01-09
RAPIDD HIGHSPEED DENTAL HANDPIECE (K003518)Dentsply Intl.2001-01-09
UNIGRAFT (K003457)Unicare Biomedical2001-01-09
STICK NET (K003334)Stick Tech , Ltd.2001-01-08
COLLAGEN PERIODONTAL MEMBRANE (K003339)Collagen Matrix, Inc.2001-01-08
PALFIQUE ESTELITE LV (K002863)Tokuyama America, Inc.2001-01-04
TEMP-BOND NE 2 (K003658)Sybron Dental Specialties, Inc.2001-01-04
STICK (K003333)Stick Tech , Ltd.2001-01-04
ASTRA TECH IMPLANTS - DENTAL SYSTEM (K002513)Astra Tech, Inc.2001-01-04
BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES (K003756)Bionx Implants, Inc.2001-01-03
FLEXICAST (K003509)American Dent-All, Inc.2001-01-02
DW 276 #3 (K003635)Ivoclar North America, Inc.2000-12-22
CLEANAIR/ CLEANWATER UNIT, MODEL 1600 (K003265)Texas Institute For Conservative Dentistry2000-12-22
MEDIADENT HDX/MMD HDX SP XRAY SENSOR (K002425)Multi Media Dental Systems, Inc.2000-12-21
VECTOR (K002122)Air Techniques, Inc.2000-12-21
DW 272 #1 (K003634)Ivoclar North America, Inc.2000-12-21
COOLBLU CURING LIGHT (K002925)Dental Systems.Com, Inc.2000-12-20
DW 273 #1 (K003632)Ivoclar North America, Inc.2000-12-20
GOLD CORE POST SOLDER (K002854)Jeneric/Pentron, Inc.2000-12-20
DW 277 #4 (K003633)Ivoclar North America, Inc.2000-12-20
GOLD CORE HF PRE SOLDER (K002815)Jeneric/Pentron, Inc.2000-12-19
CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO (K000834)Castellini S.P.A.2000-12-14
PROCLUDE (K002989)Ortek Therapeutics, Inc.2000-12-14
LEIBINGER NEURO CLIP SYSTEM (K003660)Stryker Instruments2000-12-12
LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE (K000594)Stryker Leibinger2000-12-08
ADVENT IMPLANT SYSTEM (K002614)Core-Vent Corp.2000-12-08
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS (K002798)Codman & Shurtleff, Inc.2000-12-06
JEWEL CAST III (K003037)Jeneric/Pentron, Inc.2000-12-05
GOLD CORE II (K003039)Jeneric/Pentron, Inc.2000-12-05
TKD SCALERS (K000846)Orasystems2000-12-04
FERMIT N PLUS (K003377)Ivoclar North America, Inc.2000-12-04
SPARTAN A-10 (K002753)Spartan Ultrasonics, Inc.2000-12-04
FERMIT PLUS (K003374)Ivoclar North America, Inc.2000-12-04
COLTENE AURA COMPOMER RESTORATIVE SYSTEM (K003034)Coltene/Whaledent, Inc.2000-11-30
PROCAD ADD-ON (K003373)Ivoclar North America, Inc.2000-11-28
KAVO CORUND HANDPIECE 2013 (K002708)Kavo America2000-11-28
ZAP DUAL CURING LIGHT (K002991)Soft-Core Texas, Inc.2000-11-28
SELF ETCH BONDING PRIMER (K003011)Jeneric/Pentron, Inc.2000-11-28
RENEW LS-2 (K003361)Bisco, Inc.2000-11-28
RENEW LS-1 (K003317)Bisco, Inc.2000-11-21
RACE ENDODONTIC FILE (K002709)Amc General, Inc.2000-11-17
GALAXY (K003007)Sterngold2000-11-17
HERACERAM (K002993)J.F. Jelenko & Co., Inc.2000-11-16
SURESMILE SYSTEM (K002620)Orametrix, Inc.2000-11-16
NEWGEN SYSTEM (K002619)Stryker Instruments2000-11-16
SYNTHES 1.5MM TI BROW LIFT SCREW (K002935)Synthes (Usa)2000-11-16
SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 (K002843)Sultan Chemists, Inc.2000-11-15
SOLOBOND PLUS (K003153)Voco GmbH2000-11-15
SPARTAN MTS (K002521)Spartan Marketing Group2000-11-13
SAMSUNG 10DR IMPLANT SYSTEM (K002062)Samsung Sds Co., Ltd.2000-11-09
REPLACE TPS COATED IMPLANTS (K002475)Nobel Biocare Uas, Inc.2000-11-09
CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS) (K002693)Cbs Intl. B.V.2000-11-09
CERAM-PRIME (K002502)S & C Polymer GmbH2000-11-08
WILLI GELLER CREATION AND LF PORCELAIN (K002904)Jensen Industries, Inc.2000-11-06
R&D PROJECT DW271#11A (K002872)Ivoclar North America, Inc.2000-11-02
ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT (K002374)Straumann USA2000-11-01
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