meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
31
Latest Decision
1995-09-07

Clearances · page 83 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K953592 REVOLUTION BOND E&D Dental Products, Inc. KLE Class II 1995-09-07
K953859 BOND-IT DUAL CURE ACTIVATOR Jeneric/Pentron, Inc. KLE Class II 1995-09-07
K952858 LIGHT-CURE Midwest Orthodontic Mfg. DYH Class II 1995-09-05
K953594 VULCAN Cmp Industries, LLC EJH Class II 1995-09-05
K953526 SEEK Ultradent Products, Inc. LFC Class II 1995-09-05
K953192 MODEL A15-103 Beaverstate Dental, Inc. EAY Class I 1995-09-05
K952857 PRO-LOCK Midwest Orthodontic Mfg. DYH Class II 1995-09-05
K953191 MODEL A15-101 Beaverstate Dental, Inc. EAY Class I 1995-09-05
K953380 LABORATORY SUPPLIES Steri-Oss, Inc. DZE Class II 1995-09-05
K952811 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: STAINLESS STEEL BONE-MESH/PLATE & SCREWS Implant Innovations, Inc. JEY Class II 1995-08-30
K950624 HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM Lifecore Biomedical, Inc. DZE Class II 1995-08-30
K952812 3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH/PLATE & SCREWS Implant Innovations, Inc. JEY Class II 1995-08-30
K951299 EASY PNEUMATIC CROWN AND BRIDGE REMOVER Dentco, Inc. EIS Class I 1995-08-29
K953527 PERMUALUTE INDIRECT RESTORATIVE BONDING PRIMERS Ultradent Products, Inc. KLE Class II 1995-08-29
K952422 ELASTIC IMPRESSION CREAM Teledyne Water Pik ELW Class II 1995-08-29
K953103 LAPPING TOOL KIT Steri-Oss, Inc. DZE Class II 1995-08-29
K952662 COMP=FLOW Jeneric/Pentron, Inc. EBF Class II 1995-08-28
K953026 MINIPIEZON Electro Medical Systems SA ELC Class II 1995-08-28
K953525 ULTRADENT FLOWABLE COMPOSITE Ultradent Products, Inc. EBF Class II 1995-08-28
K952619 BIO-OSS CERAMIC Geistlich-Pharma LYC Class II 1995-08-28
K944713 W&H MICRO AIR MOTOR LT25 A-Dec, Inc. EFB Class I 1995-08-28
K953119 BOSWORTH RESIN II Bosworth Co. EBI Class II 1995-08-28
K952618 BIO-OSS Geistlich-Pharma LYC Class II 1995-08-28
K944712 W&H MICRO MOTOR E25 (WITHOUT LIGHT) A-Dec, Inc. EFB Class I 1995-08-25
K953301 DENTASTIC ONE-STEP Pulpdent Corp. EMA Class II 1995-08-25
K944714 W&H CORSAIR SCALER A-Dec, Inc. EFB Class I 1995-08-25
K953217 PULPDENT TOUCHDOWN Pulpdent Corp. DYH Class II 1995-08-25
K951510 ACE BONE SCREW TACKING KIT Ace Surgical Supply Co., Inc. DZL Class II 1995-08-25
K953344 DEGUBOND ULTRA Degussa AG EJT Class II 1995-08-25
K952670 CUPRALLOY Wykle Research, Inc. EJJ Class II 1995-08-25
K953272 PULPDENT DENTASTIC II Pulpdent Corp. EMA Class II 1995-08-25
K944711 W&H AIR MOTOR A25 A-Dec, Inc. EFB Class I 1995-08-25
K953524 ULTRA-BLEND Ultradent Products, Inc. EJK Class II 1995-08-24
K950598 BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFT Bio-Interfaces, Inc. LYC Class II 1995-08-23
K935898 HYDROGUM Zhermack Dental Production ELW Class II 1995-08-22
K924408 COLLA-TEC ABSORBABLE COLLAGEN MEMBRANE Colla-Tec, Inc. LYC Class II 1995-08-22
K952240 TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION Jeneric/Pentron, Inc. EBC Class II 1995-08-18
K952693 RAMITEC PENTA Espe GmbH & Co. Kg. ELW Class II 1995-08-18
K953374 PERMADYNE GARANT 2:1 Espe GmbH & Co. Kg. ELW Class II 1995-08-18
K932333 PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR Gull Laboratories, Inc. EFB Class I 1995-08-15
K952363 OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) Ela Medical, Inc. ELA Class I 1995-08-15
K952676 BRANEMARK SYSTEM BALL ATTACHMENT SYSTEM Nobelpharma USA, Inc. DZE Class II 1995-08-11
K952353 EZ-COMP Adm, Inc. EBF Class II 1995-08-10
K952333 PLASMA ARC CURING SYSTEM American Dental Technologies, Inc. EBF Class II 1995-08-10
K953079 LIMELIGHT Pulpdent Corp. EJK Class II 1995-08-07
K952617 BIO-OSS Geistlich-Pharma LYC Class II 1995-08-07
K942380 MICRO ICS SONIC SCALER Micro Motors, Inc. ELC Class II 1995-08-07
K951609 IMZ - DENTAL IMPLANT SURGICAL TRAY Imz, GmbH DZE Class II 1995-08-01
K951611 IMZ - DENTAL IMPLANT SINGLE TOOTH ATTACHMENT Imz, GmbH DZE Class II 1995-08-01
K952234 BARRIER ALL FILM Cottrell, Ltd. EFS Class I 1995-07-31
K951689 TITANIUM MANDIBULAT RECONSTRUCTION SYSTEM Medicon EG JEY Class II 1995-07-27
K951687 MESH TITANIUM IMPLANT SYSTEM Medicon EG JEY Class II 1995-07-27
K952866 REMATITAN TITANIUM Dentauraum, Inc. EJH Class II 1995-07-27
K952867 REMANIUM:GM 700, GM 380, GM 800, GFH Dentauraum, Inc. EJH Class II 1995-07-27
K952870 REMANIUM: CS & G-SOFT Dentauraum, Inc. EJH Class II 1995-07-27
K951688 MICRO TITANIUM PLATE SYSTEM Medicon EG JEY Class II 1995-07-26
K951614 IMZ - DENTAL IMPLANT Imz, GmbH DZE Class II 1995-07-26
K945794 DURAPHAT Inpharma LBH Class II 1995-07-26
K952865 REMANIUM: 200,CS, 380, AND CD Dentauraum, Inc. EJH Class II 1995-07-26
K951615 IMZ - DENTAL IMPLANT COMPONENTS Imz, GmbH DZE Class II 1995-07-26
K951612 IMZ - DENTAL IMPLANT COMPONENTS Imz, GmbH DZE Class II 1995-07-26
K952989 WIDE STR-TP-4K, PROS STR, CLY-STR-TP 4 Implant Center of the Palm Beaches DZE Class II 1995-07-26
K951617 IMZ - DENTAL IMPLANT CASTABLE CSR ATTACHMENT Imz, GmbH DZE Class II 1995-07-26
K951690 TITANIUM MINIPLATE SYSTEM Medicon EG JEY Class II 1995-07-26
K951610 IMZ - DENTAL IMPLANT Imz, GmbH DZE Class II 1995-07-26
K951691 CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM Medicon EG JEY Class II 1995-07-26
K951618 IMZ - DENTAL IMPLANT O-RING ATTACHMENT Imz, GmbH DZE Class II 1995-07-26
K952988 WIDE SCREWS TP-4K, PROS-G4, TOOLS G4 OR 17-4 SS Implant Center of the Palm Beaches DZE Class II 1995-07-26
K944034 PERIO-MED DENTAL FLOSS Whitehill Oral Technologies, Inc. JES Class I 1995-07-25
K951734 LUMIX 70B Emix U.S.A., Inc. EAP Class II 1995-07-20
K952960 PULPDENT POST CEMENT Pulpdent Corp. EMA Class II 1995-07-19
K953027 PERMADYNE PENTA (HIGH & LOW VISCOSITY) Espe GmbH & Co. Kg. ELW Class II 1995-07-19
K945815 DENTAL KIT Constancy Ent., Inc. EKJ Class I 1995-07-19
K951239 GLOWING SPIRITS Ormco Corp. DYW Class II 1995-07-19
K952434 ENDOPORE DENTAL IMPLANT ABUTMENTS Innova Corp. DZE Class II 1995-07-19
K952868 DENTAURUM JACKET CROWN & ROOT POSTS Dentauraum, Inc. EBL Class I 1995-07-19
K951606 KIS-II IMPLANT FIXTURES Implant Center of the Palm Beaches DZE Class II 1995-07-14
K952854 PULPDENT GLASS IONOMER CEMENTS Pulpdent Corp. DYH Class II 1995-07-14
K945706 BONE DRILL Osteo Implant Corp. DZE Class II 1995-07-14
K950595 LUHR MANDIBULAR/SMALL FIXATION IMPLANTS Howmedica Corp. JEY Class II 1995-07-12
K952643 RIGHT-ON ADHESIVE BOUDING SYSTEM Tp Orthodontics, Inc. DYH Class II 1995-07-11
K950576 BIO-VENT X IMPLANT Core-Vent Corp. DZE Class II 1995-07-11
K950579 MICRO-VENT IMPLANT Core-Vent Corp. DZE Class II 1995-07-11
K950577 SWEDE-VENT IMPLANT Core-Vent Corp. DZE Class II 1995-07-11
K950575 BIO-VENT IMPLANT Core-Vent Corp. DZE Class II 1995-07-11
K945843 SAFETY PLUS Arent Fox EJI Class II 1995-07-11
K950578 SCREW-VENT IMPLANT Core-Vent Corp. DZE Class II 1995-07-11
K951813 CARIES DETECTOR Kuraray Co. LFC Class II 1995-07-11
K952351 PRECISE DENTURE BASE RESIN Dentsply Intl. EBI Class II 1995-07-07
K950533 TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY Trophy Radiologie EAP Class II 1995-06-30
K951553 3I ASYST ABUTMENT PACKAGE SYSTEM Implant Innovations, Inc. DZE Class II 1995-06-30
K952091 VUTLER G.U.M. WITH FLUORIDE John O. Butler Co. JES Class I 1995-06-28
K952644 STERI-OSS SELF TAPING IMPLANT Steri-Oss, Inc. DZE Class II 1995-06-23
K952500 COMPSEAL Jeneric/Pentron, Inc. EBF Class II 1995-06-22
K952120 TORQUE LIMITER Steri-Oss, Inc. DZE Class II 1995-06-22
K952168 TITANIUM MANDIBULAR FRACTURE SYSTEM Medicon, Inc. JEY Class II 1995-06-22
K952423 CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A715676 Rolence Enterprise Co. , Ltd. EBZ Class II 1995-06-22
K952446 TONGUE CLEAN 1-800-Tongues, Inc. LCN Class I 1995-06-22
K951271 VS11 SF Metalor Dental USA Corp. EJT Class II 1995-06-22
K951607 SUREFLEX FILES Dentsply Intl. EKJ Class I 1995-06-22

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