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.