meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
30
Latest Decision
2001-05-16

Clearances · page 65 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K011154 ELIPAR FREELIGHT Espe Dental AG EBZ Class II 2001-05-16
K011038 TAPER-LOCK DENTAL IMPLANT SYSTEM Sulzer Dental, Inc. DZE Class II 2001-05-15
K011380 MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM Bioplate, Inc. JEY Class II 2001-05-14
K010816 DENTO-PREP PARTICLE MICROBLASTER Ronvig A/S KOJ Class II 2001-05-10
K010291 ITI DENTAL IMPLANT SYSTEM Straumann USA DZE Class II 2001-05-10
K011036 RD-3008 Heraeus Kulzer, Inc. EJT Class II 2001-05-10
K010458 THE MAESTRO SYSTEM BioHorizons Implant Systems, Inc. DZE Class II 2001-05-10
K010475 D/C CORE MATERIAL Parkell, Inc. EBF Class II 2001-05-07
K010499 SYNTHES (USA) MIDFACE DISTRACTOR Synthes (Usa) JEY Class II 2001-05-03
K011022 BIOUNIVERSAL PDF Ivoclar North America, Inc. EJT Class II 2001-05-02
K011009 WHITE MTA MATERIAL Dentsply International KIF Class II 2001-05-02
K011023 D.SIGN 96 Ivoclar North America, Inc. EJT Class II 2001-05-02
K000889 SENOJ IMPLANT SYSTEM Senoj Biocare, Inc. DZE Class II 2001-04-27
K010527 SYNTHES (USA) IMF SCREWS Synthes (Usa) DZL Class II 2001-04-25
K010994 TAKE ONE BITE MODIFIED Kerr Corp. ELW Class II 2001-04-23
K010255 CAVITY VARNISH Rite-Dent Manufacturing Corp. LBH Class II 2001-04-20
K010914 BEAUTIFIL Shofu Dental Corp. EBF Class II 2001-04-20
K010630 Y-TZP POWDER AND PROCERA ALLZIRKON Procera Sandvik, Inc. EIH Class II 2001-04-17
K010195 PREMIER ULTRASONIC SCALER AND INSERTS Premier Dental Products Co. ELC Class II 2001-04-17
K010781 3M ESPE HAUR 3M Company EBF Class II 2001-04-13
K010926 R-SI-LINE METAL-BITE R-Dental Dentalerzeugnisse GmbH ELW Class II 2001-04-12
K003494 MIMIX BONE REPLACEMENT SYSTEM Biomet, Inc. LYC Class II 2001-04-09
K010196 TOTAL CURE Bisco, Inc. EBF Class II 2001-04-05
K010133 VERSALUX Centrix, Inc. EBZ Class II 2001-04-05
K004031 NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES Dental Power, Inc. EKS Class I 2001-03-28
K010414 R & D DESIGNATION AP-035 Jensen Industries, Inc. EJT Class II 2001-03-27
K010176 CALEX CONDITIONER Stephen M Koral, Dmd EJK Class II 2001-03-27
K010160 WILLI GELLER CREAPEARL Jensen Industries, Inc. ELM Class II 2001-03-27
K010240 POLYCARBOXYLATE (PCA) CEMENT Rite-Dent Manufacturing Corp. EMA Class II 2001-03-27
K010611 R & D DESIGNATION AP-047 Jensen Industries, Inc. EJT Class II 2001-03-27
K003271 MODIFICATION TO ITI DENTAL IMPLANT SYSTEM Institut Straumann AG DZE Class II 2001-03-20
K003995 SPECULITE/ORALLITE Trylon Corp. EAZ Class I 2001-03-16
K010351 INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM Inion , Ltd. JEY Class II 2001-03-15
K010352 CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM Inion , Ltd. JEY Class II 2001-03-14
K010687 BIOSORBFX AND BIOSORBPDX MESH Bionx Implants, Inc. JEY Class II 2001-03-14
K010416 HERACERAM 75 Jelenko Co. EJT Class II 2001-03-08
K010381 D.SIGN 30 Ivoclar North America, Inc. EJH Class II 2001-03-06
K003808 TAKE 1 Sybron Dental Specialties, Inc. ELW Class II 2001-03-01
K010320 MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM Depuyacromed LYC Class II 2001-03-01
K010250 TETRIC CERAM HB Ivoclar North America, Inc. EBF Class II 2001-02-28
K010386 DUO-DENT DENTAL IMPLANT Duo-Dent Dental Implant Systems, LLC DZE Class II 2001-02-27
K010267 PALFIQUE ESTELITE LV CLEAR Tokuyama America, Inc. EBF Class II 2001-02-27
K003786 SMF RESORBABLE MESHES AND SHEETS Synthes (Usa) JEY Class II 2001-02-27
K003640 MINIENDO III Sybron Dental Specialties, Inc. ELB Class II 2001-02-22
K010219 CHALLENGER DIRECT COMPOSITE International Dental Research EBF Class II 2001-02-21
K003650 PERMLASTIC 3 Sybron Dental Specialties, Inc. ELW Class II 2001-02-15
K003549 CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS Codman & Shurtleff, Inc. JEY Class II 2001-02-15
K010069 DURABOND NON-PRECIOUS CERAMIC ALLOY Matech, Inc. EJH Class II 2001-02-15
K010012 LC PROVIFILL S & C Polymer GmbH EBG Class II 2001-02-14
K010343 BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED, 3.308, 3.310,3.312, 3.314 3.316 Buck Medical Research DZE Class II 2001-02-14
K002083 LORENZ RESORBABLE DISTRACTOR SYSTEM Walter Lorenz Surgical, Inc. JEY Class II 2001-02-12
K003567 SERENOCEM, MODEL BC 010 Corinthian Medical , Ltd. NEA Class II 2001-02-12
K003493 3I CALCIUM SODIUM PHOSPHATE BONE CEMENT Biomet, Inc. LYC Class II 2001-02-09
K010044 COSMIC Jeneric/Pentron, Inc. EJT Class II 2001-02-09
K002469 IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) W&H Dentalwerk Buermoos GmbH EBW Class I 2001-02-07
K003757 THERMOFX MESH Bionx Implants, Ltd. JEY Class II 2001-02-07
K003383 PALMLIGHT Ultradent Products, Inc. EBZ Class II 2001-02-06
K003293 EXCITE DSC Ivoclar North America, Inc. KLE Class II 2001-02-06
K002075 ACE SDS 3.75MM SCREW DENTAL IMPLANT Ace Surgical Supply Co., Inc. DZE Class II 2001-02-02
K010142 OCO DENTAL IMPLANT O Co., Inc. DZE Class II 2001-02-01
K003930 FLEXTIME MAGNUM 360 Heraeus Kulzer, Inc. ELW Class II 2001-02-01
K003482 PROCLUDE-SENSITIVE Ortek Therapeutics, Inc. LBH Class II 2001-02-01
K002426 THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY Bioplate, Inc. JEY Class II 2001-01-26
K003407 SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) Ivoclar North America, Inc. EMA Class II 2001-01-26
K994060 THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE Bioplate, Inc. JEY Class II 2001-01-24
K003427 ZINC PHOSPHATE CEMENT Rite-Dent Manufacturing Corp. EMA Class II 2001-01-24
K003921 DYRACT CEM LCI COMPOMER Dentsply Intl. EMA Class II 2001-01-24
K003426 ALGINATE IMPRESSION MATERIAL Rite-Dent Manufacturing Corp. ELW Class II 2001-01-23
K003791 CAVEX TEMPORARY CEMENT Cavex Holland BV EMA Class II 2001-01-23
K003883 MOLINA ORBITAL MALAR DISTRACTOR KLS-Martin L.P. JEY Class II 2001-01-23
K010073 SPLINE DENTAL IMPLANT SYSTEM Sulzer Calcitek, Inc. DZE Class II 2001-01-19
K003286 SYMPHONY GRAFT DELIVERY SYSTEM Depuyacromed LYC Class II 2001-01-18
K003393 MAXILLARY DISTRACTOR Synthes (Usa) JEY Class II 2001-01-17
K003817 PATTERN RESIN GC America, Inc. EBG Class II 2001-01-16
K001259 2-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYSTEM Basic Dental Implant Systems, Inc. DZE Class II 2001-01-12
K003226 THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM Lifecore Biomedical, Inc. DZE Class II 2001-01-12
K003683 AVANTE CURELIGHT Jeneric/Pentron, Inc. EBZ Class II 2001-01-11
K003603 BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE Jelenko Co. EJT Class II 2001-01-10
K003387 AUROFILM NP Metalor Dental USA Corp. EJH Class II 2001-01-09
K003457 UNIGRAFT Unicare Biomedical LYC Class II 2001-01-09
K000560 SYNTHES (USA) RESORBABLE TACK SYSTEM Synthes (Usa) JEY Class II 2001-01-09
K003518 RAPIDD HIGHSPEED DENTAL HANDPIECE Dentsply Intl. EFB Class I 2001-01-09
K003334 STICK NET Stick Tech , Ltd. EBI Class II 2001-01-08
K003339 COLLAGEN PERIODONTAL MEMBRANE Collagen Matrix, Inc. NPL Class II 2001-01-08
K002863 PALFIQUE ESTELITE LV Tokuyama America, Inc. EBF Class II 2001-01-04
K003658 TEMP-BOND NE 2 Sybron Dental Specialties, Inc. EMA Class II 2001-01-04
K002513 ASTRA TECH IMPLANTS - DENTAL SYSTEM Astra Tech, Inc. DZE Class II 2001-01-04
K003333 STICK Stick Tech , Ltd. EBI Class II 2001-01-04
K003756 BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES Bionx Implants, Inc. JEY Class II 2001-01-03
K003509 FLEXICAST American Dent-All, Inc. EJH Class II 2001-01-02
K003265 CLEANAIR/ CLEANWATER UNIT, MODEL 1600 Texas Institute For Conservative Dentistry EIA Class I 2000-12-22
K003635 DW 276 #3 Ivoclar North America, Inc. EJT Class II 2000-12-22
K003634 DW 272 #1 Ivoclar North America, Inc. EJT Class II 2000-12-21
K002425 MEDIADENT HDX/MMD HDX SP XRAY SENSOR Multi Media Dental Systems, Inc. MUH Class II 2000-12-21
K002122 VECTOR Air Techniques, Inc. ELC Class II 2000-12-21
K003633 DW 277 #4 Ivoclar North America, Inc. EJT Class II 2000-12-20
K002925 COOLBLU CURING LIGHT Dental Systems.Com, Inc. EBZ Class II 2000-12-20
K002854 GOLD CORE POST SOLDER Jeneric/Pentron, Inc. EJT Class II 2000-12-20
K003632 DW 273 #1 Ivoclar North America, Inc. EJS Class II 2000-12-20
K002815 GOLD CORE HF PRE SOLDER Jeneric/Pentron, Inc. EJT Class II 2000-12-19

12,679 clearances in the Dental panel. Data: openFDA.