meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
37
Latest Decision
2004-08-04

Clearances · page 55 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K041886 PROVISO Scientific Pharmaceuticals, Inc. EBG Class II 2004-08-04
K040343 TEMP F Novocol, Inc. EMA Class II 2004-08-03
K041378 BIO 60 Kodent, Inc. EJT Class II 2004-08-02
K041707 CERCON CERAM EXPRESS CERAMIC SYSTEM Dentsply Intl. EIH Class II 2004-07-30
K041368 DENTIUM CO., LTD. IMPLANTIUM Dentium Co., Ltd. DZE Class II 2004-07-29
K040417 PILLAR PALATAL IMPLANT SYSTEM Restore Medical, Inc. LRK Class II 2004-07-28
K041070 STRAUMANN TEMPORARY COPING The Straumann Co. NHA Class II 2004-07-23
K041312 NOBELRONDO DENTAL CERAMIC-ALUMINA Nobel Biocare Uas, Inc. EIH Class II 2004-07-23
K041938 MAXIMUS OS (OVERDENTURE SYSTEM) BioHorizons Implant Systems, Inc. DZE Class II 2004-07-22
K041759 ACE CONNECT INTERNAL CONNECTION Ace Surgical Supply Co., Inc. DZE Class II 2004-07-22
K041474 MAXCEM Sybron Dental Specialties, Inc. EMA Class II 2004-07-21
K040465 LATIT FLOW Ab Ardent EBF Class II 2004-07-20
K041324 CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER Lifecore Biomedical, Inc. LYC Class II 2004-07-19
K040382 CRANEX BASEX D OR CRANEX EXCEL D Soredex Palodex Group OY EHD Class II 2004-07-13
K041645 DDS-ZR Charles Scharf EIH Class II 2004-07-09
K031701 OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM Osteomed LP NEI Class II 2004-07-08
K040988 ZIRCON-F PROPHYLAXIS PASTE Pascal Co., Inc. EJR Class I 2004-07-07
K040416 SONICARE ADVANCE TOOTHBRUSH, MODEL 4900 Philips Oral Healthcare, Inc. JEQ Class I 2004-07-02
K040946 ANKYLOS DENTAL IMPLANT SYSTEM Friadent GmbH DZE Class II 2004-07-01
K033984 STRAUMANN DENTAL IMPLANT SYSTEM Institut Straumann AG DZE Class II 2004-06-30
K040674 IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES Anthogyr EFA Class I 2004-06-30
K040952 PRELUDE Danville Materials, Inc. KLE Class II 2004-06-29
K041580 IMAGERAYI Henry Schein, Inc. MUH Class II 2004-06-29
K041471 G-BOND GC America, Inc. KLE Class II 2004-06-29
K041398 GC FUSION GC America, Inc. ELW Class II 2004-06-25
K041372 SMARTLITE PS PEN-STYLE LED CURING LIGHT Dentsply International EBZ Class II 2004-06-24
K040063 INSPEKTOR PRO Inspektor Dental Care BV NBL Class II 2004-06-24
K033785 PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE Discus Dental, Inc. EJR Class I 2004-06-18
K041303 LED TURBO-PEN Apoza Enterprise Co., Ltd. EBZ Class II 2004-06-18
K040874 RED, WHITE & BLUE Allesee Orthodontic Appliances NXC Class II 2004-06-18
K041229 MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL) Cosmedent, Inc. ELW Class II 2004-06-17
K030195 BBP BONE SUBSTITUTES Oct, USA, Inc. LYC Class II 2004-06-17
K040906 CALIBRA CEMENT Dentsply Intl. EMA Class II 2004-06-16
K041343 XENO NM LIGHT CURED DENTAL ADHESIVE Dentsply International KLE Class II 2004-06-16
K041141 DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125 Dentsply Intl. EFB Class I 2004-06-16
K041335 PTM SYSTEM Dentsply International EIH Class II 2004-06-16
K041402 MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS Implant Innovations, Inc. DZE Class II 2004-06-16
K041050 DIGORA OPTIME (OR DIGORA ONTIME) Soredex Palodex Group OY MUH Class II 2004-06-15
K040956 HILUX LEDMAX 3 First Medical Infection Control Associates, Inc. EBZ Class II 2004-06-14
K040661 RADENT PROPHY PASTE Pascal Co., Inc. EJR Class I 2004-06-09
K040807 MIS DENTAL IMPLANT SYSTEM Mis - Implant Technologies , Ltd. DZE Class II 2004-06-09
K041385 MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM Schick Technologies, Inc. EAP Class II 2004-06-07
K041124 IRRIGATION TUBING SET 2.2M AND 3.8M W&H Dentalwerk Burmoos EBW Class I 2004-06-07
K040994 COSMEDENT CORE PASTE Cosmedent, Inc. EBF Class II 2004-06-03
K040650 BONAMATES SERIES Biotech One, Inc. JEY Class II 2004-06-03
K040748 ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM Takara Belmont USA, Inc. EHD Class II 2004-06-02
K040891 KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES) KLS-Martin L.P. DZE Class II 2004-05-28
K041283 PROCERA BRIDGE ZIRCONIA Nobel Biocare AB ELL Class II 2004-05-28
K041275 PROCERA ABUTMENT OCTAGON Nobel Biocare Uas, Inc. NHA Class II 2004-05-27
K040672 PORTA REFLEX Wieland Dental + Technik GmbH & Co. KG EJT Class II 2004-05-27
K041236 PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 Nobel Biocare AB NHA Class II 2004-05-26
K040881 METACRYL Great Lakes Orthodontics, Ltd. EBI Class II 2004-05-25
K041295 RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANT Institut Straumann AG NHA Class II 2004-05-24
K040153 I-TEC PORTABLE DENTAL OPERATORY Indigenous Peoples Technology and Education Center EBW Class I 2004-05-21
K040895 INTEGRITY TEMPORARY CEMENT Dentsply Intl. EMA Class II 2004-05-21
K040524 PORTA SOLDER 1090 W Wieland Dental + Technik GmbH & Co. KG EJT Class II 2004-05-20
K040859 HERACERAM PRESS Heraeus Kulzer, Inc. EIH Class II 2004-05-20
K040951 SR ADORO Ivoclar Vivadent, Inc. EBG Class II 2004-05-19
K040795 MULTICORE HB; MULTICORE FLOW Ivoclar Vivadent, Inc. EBF Class II 2004-05-17
K041028 CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL Crown Delta Corp. ELW Class II 2004-05-14
K030425 LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER Walter Lorenz Surgical, Inc. JEY Class II 2004-05-14
K041098 COOL TEMP NATURAL Coltene AG EBG Class II 2004-05-13
K040857 MODIFICATION TO ADPER PROMPT 3M Espe AG Dental Products KLE Class II 2004-05-10
K040983 LORENZ SELF-DRILLING IMF SCREW Walter Lorenz Surgical, Inc. DZE Class II 2004-05-05
K040646 STRAUMANN GRANULES The Straumann Co. LYC Class II 2004-05-03
K040161 SONA PILLOW Sleep Devices, Inc. MYB Class II 2004-04-30
K040469 THE STRAUMANN ORTHO IMPLANT SYSTEM The Straumann Co. OAT Class II 2004-04-30
K033198 APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2 Apoza Enterprise Co., Ltd. ELC Class II 2004-04-30
K040393 RIVA LUTING Southern Dental Industries, Inc. EMA Class II 2004-04-30
K033755 MINRAY Soredex Palodex Group OY EHD Class II 2004-04-29
K031664 ELEMENTS OBTURATION UNIT Sybron Endo/Analytic EKR Class I 2004-04-28
K040808 MINI L.E.D. OEM MODULE Satelec EBZ Class II 2004-04-28
K040573 NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236 Nobel Biocare Uas, Inc. NHA Class II 2004-04-28
K033098 OSTEOGEN SBRG Impladent , Ltd. LYC Class II 2004-04-27
K033171 NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING Northern Implants, LLC DZE Class II 2004-04-27
K040567 GC INITIAL MC, AL AND LF GC America, Inc. EIH Class II 2004-04-22
K033699 LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586 Zest Anchors, Inc. DZE Class II 2004-04-22
K040396 ULTRASONIC SCALER ELEGANCE MS-10 (25K) Rolence Enteprise, Inc. ELC Class II 2004-04-22
K033092 THE GNATHOMETER Ortho Gnathics, LLC JEY Class II 2004-04-21
K040117 UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT Arrow Industries, LLC EIA Class I 2004-04-21
K033630 MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK Rhein 83 Srl DZE Class II 2004-04-21
K040236 PULPDENT VLC RESIN CEMENT Pulpdent Corporation EMA Class II 2004-04-20
K040116 HAWK INTRAORAL CAMERA AND ACCESSORIES Dxm Co., Ltd. EIA Class I 2004-04-20
K040169 SYNTHES MANDIBLE EXTERNAL FIXATOR Synthes (Usa) MQN Class II 2004-04-14
K040599 PARKELL RESIN GLAZE Parkell, Inc. EBD Class II 2004-04-09
K040714 HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT Innova Corp. DZE Class II 2004-04-09
K033925 BIOFREE Dental Components, Inc. EIA Class I 2004-04-07
K040643 BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES Branemark Integration AB DZE Class II 2004-04-07
K040769 STRUCTUR 2 SC Voco GmbH EBG Class II 2004-04-07
K040556 TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY Eastman Kodak Company EHD Class II 2004-04-07
K040614 BLUEWAND LED DENTAL CURING WAND SYSTEM J.L. Blosser, Inc. EBZ Class II 2004-04-07
K040375 IDEAL 1 ORTHODONTIC BAND CEMENT Dentsply Intl. DYH Class II 2004-04-02
K040797 BRITESMILE MASKING CREAM Britesmile, Inc. EIE Class I 2004-04-02
K030989 OSTEOSORB TACK FIXATION SYSTEM Noviace Corporation JEY Class II 2004-04-01
K040369 STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM Stryker Instruments DZJ Class II 2004-04-01
K024186 X-VIEW Sometech Corporation MUH Class II 2004-04-01
K040144 QUIXX POSTERIOR RESTORATIVE Dentsply International EBF Class II 2004-04-01
K040083 SYNTHES EXTERNAL MIDFACE DISTRACTOR Synthes (Usa) MQN Class II 2004-03-31
K033074 INION GTR BIODEGRADABLE MEMBRANE SYSTEM Inion , Ltd. NPK Class II 2004-03-31
K040635 CARRARA INTERACTION CERAMIC SYSTEM Dentsply Intl. EIH Class II 2004-03-30

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