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Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
34
Latest Decision
1991-03-15

Clearances · page 99 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K903538 WIRON 99 DENTAL CASTING ALLOY Leach and Dillon Co., Inc. EJH Class II 1991-03-15
K905131 DURAFILL COLOR VS Kulzer, Inc. EBF Class II 1991-03-15
K905032 MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL Parkell ELW Class II 1991-03-15
K903498 RETAINER, SCREW EXPANSION ORTHODONTIC Masel Industries, Inc. EJF Class I 1991-03-12
K905542 LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS Lares Research, Inc. EFB Class I 1991-03-11
K905543 LARES APOLLO CS/CP/C Lares Research, Inc. EBZ Class II 1991-03-11
K910303 SYSNPAR PORCELAIN Jeneric/Pentron, Inc. ELL Class II 1991-03-08
K905541 LARES 757 WORKHORSE HIGHSPEED HANDPIECE Lares Research, Inc. EFB Class I 1991-03-07
K905461 PROCEDURE KIT/ROUTINE DENTAL PROCEDURES Angiosystems, Inc. EKS Class I 1991-03-05
K905640 SOLID CORE GUTTA PERCHA CARRIER The Hygenic Corp. EKS Class I 1991-03-05
K905436 NOBELPHARMA DRILLING EQUIPMENT DEC 500 Nobelpharma USA, Inc. DZE Class II 1991-03-04
K902434 DIA HEALING CAP Dental Imaging Assoc., Inc. DZE Class II 1991-02-27
K905620 MODIFIED SITE PERISTALTIC FOOTSWITCH Site Microsurgical Systems, Inc. EBW Class I 1991-02-27
K905302 DENTHESIVE Kulzer, Inc. KLE Class II 1991-02-26
K905329 WILL-CERAM W Ivoclar North America, Inc. EJT Class II 1991-02-26
K905327 MAXIGOLD Ivoclar North America, Inc. EJT Class II 1991-02-26
K905321 PLATINUM FOIL, VARIOUS SIZES Ivoclar North America, Inc. EIH Class II 1991-02-26
K904812 COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE Alpha-Dent EBF Class II 1991-02-26
K905320 WLW Ivoclar North America, Inc. EJT Class II 1991-02-26
K900179 SCREW-VENT ENDOSSEOUS IMPLANT ABUTMENTS Core-Vent Corp. DZE Class II 1991-02-20
K905401 ASEPTIMINI UNIT, ADU-10 Aseptico, Inc. EIA Class I 1991-02-20
K902435 DIA IMPRESSION COPING Dental Imaging Assoc., Inc. DZE Class II 1991-02-20
K900181 MICRO-VENT ENDOSSEOUS IMPLANT ABUTMENTS Core-Vent Corp. DZE Class II 1991-02-20
K910038 LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM Walter Lorenz Surgical, Inc. JEY Class II 1991-02-20
K905476 STOMADENT TM Dentsply Intl. EBF Class II 1991-02-20
K905724 IONOBOND Micro-Vac, Inc. EJK Class II 1991-02-19
K900180 CORE-VENT ENDOSSEOUS IMPLANT ABUTMENTS Core-Vent Corp. DZE Class II 1991-02-19
K905188 PERIO PIK Teledyne Water Pik EFS Class I 1991-02-15
K905155 HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES Star Dental Mfg. Co. EFB Class I 1991-02-13
K900694 CASTABLE ABUTMENTS Calcitek, Inc. DZE Class II 1991-02-11
K904611 INTERPORE CYLINDRICAL HEX IMPLANT Interpore Intl. DZE Class II 1991-02-05
K896099 DIGIGRAPH DIAGNOSTIC WORK/STATION Dolphin Imaging Systems EAG Class II 1991-01-31
K905011 ORAL PHARYNGEAL CLEANSING DEVICE Concord/Portex EIA Class I 1991-01-31
K904948 PM2002 CC AND PM2002 EC Planmeca USA, Inc. EIA Class I 1991-01-30
K900136 CEROS 80 (HA) Mathys Corp. LYC Class II 1991-01-29
K904605 TITANIUM COC ABUTMENT HEADS FOR IMZ Implant Support Systems, Inc. DZE Class II 1991-01-29
K905761 TYPE III DENTAL GOLD ALLOY FOR CROWN & BRIDGE APP. Argen Precious Metals, Inc. EJT Class II 1991-01-29
K902928 DEVICE PART NUMBER DPI-1106 IMPLANT Minimatic Implant Technology DZE Class II 1991-01-29
K905811 ARGENCO 52HN Argen Precious Metals, Inc. EJT Class II 1991-01-29
K905090 FEEL FRESH TOOTHBRUSH KIT Fresh Appeal , Ltd. EFW Class I 1991-01-25
K904850 DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555 Micro Motors, Inc. EFS Class I 1991-01-25
K905328 WILL-CERAM BRUSHES, SUPER BRUSH KIT Ivoclar North America, Inc. EIH Class II 1991-01-17
K905322 MIDIGOLD 50 Ivoclar North America, Inc. EJT Class II 1991-01-16
K905387 DEGUDENT GS Degussa AG EJT Class II 1991-01-15
K900099 THE O-RING SYSTEM - ORS Attachments Intl., Inc. DZE Class II 1991-01-15
K905319 VARIOUS Ivoclar North America, Inc. EJT Class II 1991-01-15
K904711 BC 1220 ANALOG - IMPLANT BODY Minimatic Implant Technology DZE Class II 1991-01-14
K901927 HA-TI (HAND-TITANIUM SCREW) IMPLANT Mathys Corp. of North America DZE Class II 1991-01-04
K904695 GDC-1501 Deringer-Ney, Inc. EJT Class II 1991-01-02
K904927 HENNSON INTERNATIONAL DENTAL CAD/CAM SYSTEM Hennson Intl., Inc. ELW Class II 1990-12-28
K905197 THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM Ormco Corp. EJT Class II 1990-12-27
K903113 CGA-112 COPING GOLD ALLOY Minimatic Implant Technology DZE Class II 1990-12-27
K904034 TEMPORARY DENTAL CEMENT Medical Device Inspection Co., Inc. EMA Class II 1990-12-27
K903039 A-1101 CAST ABUTMENT Minimatic Implant Technology DZE Class II 1990-12-26
K905330 HARMONY LINE ALLOYS Ivoclar North America, Inc. EJT Class II 1990-12-24
K905326 MINIGOLD Ivoclar North America, Inc. EJT Class II 1990-12-24
K905323 WILL-CERAM Y AND WILL -CERAM Y-1 Ivoclar North America, Inc. EJT Class II 1990-12-24
K905324 WILL-CERAM W-1 Ivoclar North America, Inc. EJT Class II 1990-12-24
K904671 QAR HANDPIECE Collagen Corp. EFB Class I 1990-12-21
K905325 X-L AND X-LX Ivoclar North America, Inc. EJT Class II 1990-12-21
K904527 KAPPER Senair-Mot EJI Class II 1990-12-21
K904614 GDC-1475 Deringer-Ney, Inc. EJT Class II 1990-12-19
K905382 SCRIBBON Varnum Corp. JES Class I 1990-12-17
K903284 YOUNG PROPHY SYSTEM, PS UNIT Young Dental Manufacturing Co. 1, LLC KOJ Class II 1990-12-17
K903971 ARGENCO 26B Argen Precious Metals, Inc. EJS Class II 1990-12-17
K903481 ALPHA-FILL, ALPHA-CEM, AND ALPHA-SILVER Dental Foremost EBF Class II 1990-12-17
K905220 MONOBOND S Ivoclar North America, Inc. EBF Class II 1990-12-17
K904914 DENTAL VACUUM INJECTION TRAY The Lebanon Vac-Tray Corp. KMT Class I 1990-12-17
K905205 DW 235 Ivoclar North America, Inc. EJJ Class II 1990-12-17
K905221 SPECIAL BOND II Ivoclar North America, Inc. EBF Class II 1990-12-17
K902969 SCREW-VENT ENDOSSEOUS HA COATED DENTAL IMPLANTS Core-Vent Corp. DZE Class II 1990-12-17
K902295 OSTEOGRAF/N NATURAL HYDROXYLAPATITE, 40-60 MESH Ceramed Corp. LYC Class II 1990-12-11
K902809 BRACKET, METAL, ORTHODOTNIC Masel Industries, Inc. EJF Class I 1990-12-07
K904401 BATTERY-POWERED TOOTHBRUSH The B & F System, Inc. JEQ Class I 1990-12-07
K904724 CONQUEST DIRECT FILLING COMPOSITE (DFC) Jeneric/Pentron, Inc. KLE Class II 1990-12-07
K904279 PAROJECT ANESTHETIC SYRINGE Ronvig Instruments, Ltd. EGM Class II 1990-12-07
K904296 LYSTA HYGIENIST III SCALER Prodent Intl., Inc. ELC Class II 1990-12-05
K904199 HORIZON REGULAR ETCHING GEL Horizon Chemical Co. EJR Class I 1990-12-05
K903672 DENE BRIDGE Dirotian Pty. , Ltd. EKO Class II 1990-12-05
K903041 A-1107 ABUTMENT (FIXED) Minimatic Implant Technology DZE Class II 1990-11-30
K904482 STAT.BR TM Kerr Corporation (Danbury) ELW Class II 1990-11-29
K903040 A-1103 ABUTMENT (REMOVABLE) Minimatic Implant Technology DZE Class II 1990-11-26
K904460 SATC-1114, SHOULDER ABUTMENT TRANSFER COPING Minimatic Implant Technology DZE Class II 1990-11-20
K903044 TC-1111 TRANSFER PIN Minimatic Implant Technology DZE Class II 1990-11-20
K902930 DEVICE PART NUMBER: SVD-3S DRILL Minimatic Implant Technology DZE Class II 1990-11-20
K903518 ABO-1122 ANALOG BALL OVERDENTURE Minimatic Implant Technology DZE Class II 1990-11-20
K902836 MICROETCHER Danville Engineering, Inc. KOJ Class II 1990-11-20
K904096 PHOTAC-BOND Espe GmbH (Us) EJK Class II 1990-11-19
K900433 SMOOTH STAPLE IMPLANT Interphase Implants, Inc. MDL Class II 1990-11-16
K903062 HS-1113 HEALING SCREW - REV. A Minimatic Implant Technology DZE Class II 1990-11-13
K900986 THERMAFIL ENDODONTIC OBTURATOR Tulsa Dental Products, Ltd. EKM Class I 1990-11-13
K903112 PART NUMBER: TA-1118 TAP Minimatic Implant Technology DZE Class II 1990-11-13
K903114 PP-1105 PARALLEL PIN Minimatic Implant Technology DZE Class II 1990-11-13
K902931 DEVICE PART NUMBER: PD-12 PILOT DRILL Minimatic Implant Technology DZE Class II 1990-11-13
K903517 AIB-1120 ANALOG-IMPLANT BODY Minimatic Implant Technology DZE Class II 1990-11-13
K903115 DG-1109 DEPTH GAGE Minimatic Implant Technology DZE Class II 1990-11-13
K904555 DURAFILL FLOW Kulzer, Inc. EBF Class II 1990-11-13
K902325 DENTAL CLEANING RINGS H. Bernath & Assoc. JES Class I 1990-11-13
K903516 BO-1121 BALL OVERDENTURE ATTACHMENT Minimatic Implant Technology DZE Class II 1990-11-13
K903042 AA-1110 ANALOG ABUTMENT Minimatic Implant Technology DZE Class II 1990-11-13

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