meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
31
Latest Decision
2001-11-29

Clearances · page 63 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K013049 NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE Dennis R. Bailey, Dds LRK Class II 2001-11-29
K013682 MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM Basic Dental Implant Systems, Inc. DZE Class II 2001-11-28
K013185 TCM ENDO III NOUVAG AG EFA Class I 2001-11-28
K012908 BIOPLATE RESORBABLE BONE SCREW Bioplate, Inc. DZL Class II 2001-11-28
K012877 HIGH GOLD PALLADIUM FREE CERAMIC SOLDER Ivoclar USA, Inc. EJT Class II 2001-11-21
K012841 DUO PAL 6, ORDER-NO.: 2154 Wieland Edelmetalle GmbH & Co. EJS Class II 2001-11-20
K012910 THE BIOPLATE MANDIBLE FIXATION SYSTEM Bioplate, Inc. JEY Class II 2001-11-20
K012944 POWER DRIVE Mediteam AB EKX Class I 2001-11-20
K013227 SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT Sulzer Dental, Inc. DZE Class II 2001-11-19
K012882 BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060 Thermoelastic Technologies, Inc. EBI Class II 2001-11-14
K012720 TULSA CONTRA ANGLES Dentsply Intl. EFB Class I 2001-11-08
K011799 EVERSTICKNET Stick Tech , Ltd. EBI Class II 2001-11-05
K011788 EVERSTICK Stick Tech , Ltd. EBI Class II 2001-11-05
K012794 PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT Prime Dental Manufacturing, Inc. EBF Class II 2001-11-05
K012843 PORTADUR P 2, MODEL #2031 Wieland Edelmetalle GmbH & Co. EJT Class II 2001-11-02
K012828 PORTA SMK 82, MODEL 2032 Wieland Edelmetalle GmbH & Co. EJS Class II 2001-11-01
K012827 PORTA AURIUM, MODEL 2067 Wieland Edelmetalle GmbH & Co. EJT Class II 2001-11-01
K012826 BIOPORTA G, MODEL 2052 Wieland Edelmetalle GmbH & Co. EJT Class II 2001-11-01
K012835 PORTA MAXIMUM, MODEL# 2066 Wieland Edelmetalle GmbH & Co. EJT Class II 2001-11-01
K012517 CEREC3 VITABLOCKS Sirona Dental Systems GmbH ELW Class II 2001-11-01
K012834 PORTA GEO TI MODEL #2004 Wieland Edelmetalle GmbH & Co. EJT Class II 2001-11-01
K012767 S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL S & C Polymer GmbH ELW Class II 2001-11-01
K012761 PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT Prime Dental Manufacturing, Inc. EBC Class II 2001-11-01
K012831 BIO PORTADUR, ORDER-NO.:2017 Wieland Edelmetalle GmbH & Co. EJT Class II 2001-11-01
K013336 XANTALGIN CRONO Cavex Holland BV ELW Class II 2001-10-29
K013375 BELLEGLASS HP OPAQUE 2 Kerr Dental Materials Center EBF Class II 2001-10-29
K013198 FUJI VII CAPSULE GC America, Inc. EMA Class II 2001-10-29
K013230 CERCON BASE Degussa - Ney Dental, Inc. EIH Class II 2001-10-25
K012717 LIFE 2 Sybron Dental Specialties, Inc. EJK Class II 2001-10-25
K012673 PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM Prime Dental Manufacturing, Inc. DYH Class II 2001-10-24
K012840 EURO 45, ORDER-NO.: 2064 Wieland Edelmetalle GmbH & Co. EJS Class II 2001-10-23
K012838 ERO50, ORDER-NO.: 2070 Wieland Edelmetalle GmbH & Co. EJT Class II 2001-10-23
K013325 POINT 4 FLOWABLE 2 Kerr Dental Materials Center EBF Class II 2001-10-23
K013237 STATUSBLUE Dmg USA, Inc. ELW Class II 2001-10-22
K012529 ROK Southern Dental Industries, Ltd. EBF Class II 2001-10-22
K011502 CRYSTAL AND CRYSTAL-CARE IMPLANTS SYSTEM Crystal-Seal Dental Implants DZE Class II 2001-10-22
K012528 ICE Southern Dental Industries, Ltd. EBF Class II 2001-10-22
K013277 ASTRALIS 7, MODEL 557545 Ivoclar Vivadent, Inc. EBZ Class II 2001-10-22
K013275 ASTRALIS 10, MODELS # 559588, 561859 Ivoclar Vivadent, Inc. EBZ Class II 2001-10-19
K013236 LUXABITE Dmg USA, Inc. ELW Class II 2001-10-17
K013176 MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE Afp Imaging Corp. EHD Class II 2001-10-16
K012542 REVOTEK LC GC America, Inc. EBC Class II 2001-10-16
K013179 LUXAGLAZE Dmg USA, Inc. EBD Class II 2001-10-12
K013129 RHODIA DENTAL PUTTY IMPRESSION MATERIAL Rhodia, Inc. ELW Class II 2001-10-10
K013140 RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL Rhodia, Inc. ELW Class II 2001-10-10
K012354 SNOWPOST, SNOWLIGHT Danville Materials, Inc. ELR Class I 2001-10-10
K012427 PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT Specialites Septodont EAT Class II 2001-10-09
K010127 W & H ASSISTINA A-Dec, Inc. EFB Class I 2001-10-05
K012505 SOPRO595 INTRA ORAL CAMERA Sopro EIA Class I 2001-10-05
K013039 INION CPS 2.0 ORTHOGNATHIC PLATE Inion , Ltd. JEY Class II 2001-10-05
K012142 THE QUIET SLEEPER Precision Dental Laboratories, Inc. LRK Class II 2001-10-04
K013009 BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2 Sybron Dental Specialties, Inc. EBF Class II 2001-10-03
K013008 NEXUS 2 MODIFIED Sybron Dental Specialties, Inc. EMA Class II 2001-10-02
K012946 SUNLITELED MODEL #2810 Kinetic Instruments, Inc. EBZ Class II 2001-10-02
K013007 BELLEGLASS HP ENAMEL 2 Sybron Dental Specialties, Inc. EBF Class II 2001-10-01
K012144 CYTOFLEX Unicare Biomedical, Inc. LYC Class II 2001-10-01
K012914 SONICWAVE SONIC PLAQUE REMOVER Homedics, Inc. JEQ Class I 2001-10-01
K003191 MIS IMPLANT SYSTEM DECIVE Mis Implants Technologies , Ltd. DZE Class II 2001-09-28
K012911 3I LOCATER ABUTMENT SYSTEM Implant Innovations, Inc. DZE Class II 2001-09-28
K010619 UCLA AND UNIVERSAL ABUTMENTS Diamodent DZE Class II 2001-09-28
K000035 OMNICARE DENTAL IMPLANT SYSTEM Omnicare Dental Implant Center DZE Class II 2001-09-28
K010882 BLUE SKY BIO DENTAL IMPLANT SYSTEM Blue Sky Bio DZE Class II 2001-09-28
K011574 UNIPLANT DENTAL IMPLANT SYSTEM Universal Implant Systems, Inc. DZE Class II 2001-09-28
K010467 UNIVERSAL DENTAL COPING (UDC) Paxmed International DZE Class II 2001-09-28
K012160 COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408 Premier Dental Products Co. EBF Class II 2001-09-27
K991250 QUANTUM VERSATILITY IMPLANT SYSTEM Quantum Bioengineering, Ltd. DZE Class II 2001-09-20
K002241 QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM Quantum Bioengineering, Ltd. DZE Class II 2001-09-20
K012082 OPTIBOND SOLO PLUS ACTIVATOR Sybron Dental Specialties, Inc. KLE Class II 2001-09-20
K011223 QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM Paxmed International DZE Class II 2001-09-20
K003620 NSI HEXED AND NON-HEXED IMPLANT SYSTEM Nsi DZE Class II 2001-09-19
K012047 3I CALCIUM SULFATE BONE CEMENT Implant Innovations, Inc. LYC Class II 2001-09-19
K012413 MACROPORE FX, PS, NS, LP Macropore Biosurgery, Inc. JEY Class II 2001-09-18
K012032 FIRST SPEP Bisco, Inc. DYH Class II 2001-09-17
K010849 VERTEX ETCHANT Apex Dental Materials, Inc. EBF Class II 2001-09-14
K012733 CARIES DETECTOR Kuraray Medical, Inc. LFC Class II 2001-09-14
K012735 CLEARFIL DC CEMENT Kuraray Medical, Inc. EMA Class II 2001-09-14
K012734 CLEARFIL NEW BOND Kuraray Medical, Inc. KLE Class II 2001-09-14
K012737 CHROMA ZONE COLOR STAIN Kuraray Medical, Inc. EBF Class II 2001-09-14
K012742 TEETHMATE F-1 Kuraray Medical, Inc. EBC Class II 2001-09-14
K012740 CLEARFIL AP-X Kuraray Medical, Inc. EBF Class II 2001-09-14
K011338 OTO-CEM Ototech, Inc. NEA Class II 2001-09-13
K012730 CLEARFIL PORCELAIN BOND ACTIVATOR Kuraray Medical, Inc. KLE Class II 2001-09-13
K012707 ESTENIA Kuraray Medical, Inc. EBF Class II 2001-09-13
K012729 CLEARFIL REPAIR Kuraray Medical, Inc. KLE Class II 2001-09-13
K012705 CLEARFIL PHOTO CORE Kuraray Medical, Inc. EBF Class II 2001-09-11
K011926 ELEC-MATE E Nakanishi, Inc. EBW Class I 2001-09-11
K011403 SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE Orthogen Corp. LYC Class II 2001-09-11
K012442 MODIFICATION TO CLEARFIL SE BOND Kuraray Medical, Inc. KLE Class II 2001-09-10
K012703 CLEARFIL CORE NEW BOND Kuraray Medical, Inc. EBF Class II 2001-09-10
K012704 CLEARFIL ST OPAQUER Kuraray Medical, Inc. EBF Class II 2001-09-10
K011908 OPTIBOND SOLO PLUS 3 Kerr Dental Materials Center EBC Class II 2001-09-06
K012360 LC TEMPORARY FILLING Parkell, Inc. EBG Class II 2001-09-06
K012441 PANAVIA F Kuraray Medical, Inc. EMA Class II 2001-09-06
K012055 3.25MM SPLINE TWIST IMPLANT Sulzer Dental, Inc. DZE Class II 2001-09-06
K012438 MODIFICATION TO PANAVIA 21 Kuraray Medical, Inc. EMA Class II 2001-09-05
K012440 MODIFICATION TO CLEARFIL LINER BOND 2V Kuraray Medical, Inc. KLE Class II 2001-09-05
K012180 A-WEAR Bisco, Inc. EBF Class II 2001-09-05
K011820 DENTORIUM CONVERTIBLE ACRYLIC Nats Corp. EBI Class II 2001-09-05
K010935 BRITESMILE BARRIER MATERIAL Britesmile, Inc. EIE Class I 2001-09-05
K011854 TOKUYAMA M-BOND Tokuyama America, Inc. EMA Class II 2001-09-04

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