Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 32
- Latest Decision
- 2001-09-04
Clearances · page 64 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K011674 | DC - CRISTAL | Austenal, Inc. | EIH | Class II | 2001-09-04 |
| K011785 | NOVEL PRINT CYAN ALGINATES | Manufacturera Dental Continental | ELW | Class II | 2001-09-04 |
| K012436 | MODIFICATION TO ALLOY PRIMER | Kuraray Medical, Inc. | KLE | Class II | 2001-09-04 |
| K012405 | EXTRUDE MODIFIED | Sybron Dental Specialties, Inc. | ELW | Class II | 2001-09-04 |
| K012432 | MODIFICATION TO CLEARFIL PHOTO BOND | Kuraray Medical, Inc. | KLE | Class II | 2001-09-04 |
| K012341 | TRANSLUX ENERGY | Heraeus Kulzer, Inc. | EBZ | Class II | 2001-08-30 |
| K012322 | OPTIBOND 2 | Sybron Dental Specialties, Inc. | KLE | Class II | 2001-08-30 |
| K011659 | GPW-SF | Gateway Alloys, Inc. | EJT | Class II | 2001-08-27 |
| K011661 | CONCORD 88 | Gateway Alloys, Inc. | EJT | Class II | 2001-08-27 |
| K012321 | POINT 4 FLOWABLE | Sybron Dental Specialties, Inc. | EBF | Class II | 2001-08-27 |
| K012174 | ERIS LAYERING MATERIALS | Ivoclar North America, Inc. | EIH | Class II | 2001-08-27 |
| K011698 | STRAUMANN GBR SYSTEM | Institut Straumann AG | JEY | Class II | 2001-08-23 |
| K012307 | LUXACORE/LUXACORE DUAL | Dmg USA, Inc. | EBF | Class II | 2001-08-23 |
| K011762 | HI-WAVE; POUR-PLUS | Denplus, Inc. | EBI | Class II | 2001-08-23 |
| K012316 | PERMACEM / PERMACEM DUAL | Dmg USA, Inc. | EMA | Class II | 2001-08-23 |
| K012231 | AVANTE MICRO CRYSTAL SYSTEM | Jeneric/Pentron, Inc. | EIH | Class II | 2001-08-23 |
| K012757 | ITI DENTAL IMPLANT SYSTEM | Straumann USA | DZE | Class II | 2001-08-22 |
| K012303 | JEL-20 | J.F. Jelenko & Co., Inc. | EJS | Class II | 2001-08-22 |
| K011333 | CERCON CERAM | Degussa - Ney Dental, Inc. | EIH | Class II | 2001-08-20 |
| K003552 | ITI DENTAL IMPLANT SYSTEM | Institut Straumann SA | DZE | Class II | 2001-08-17 |
| K011801 | FUTURA TOPCAP NON GAMMA-2 | Ab Ardent | EJJ | Class II | 2001-08-16 |
| K012156 | IMAGINE H.E. | Wieland Edelmetalle GmbH & Co. | EIH | Class II | 2001-08-16 |
| K010547 | VERTEX SEALAND L/C ORTHODONTIC SEALANT | Apex Dental Materials, Inc. | KLE | Class II | 2001-08-16 |
| K011491 | HELIOSEAL CLEAR CHROMA | Ivoclar North America, Inc. | EBC | Class II | 2001-08-16 |
| K991822 | ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT SYSTEM, LONG NECK, MODEL STI RT LN LENGTH | Dr. Ihde Dental AG Switzerland | DZE | Class II | 2001-08-15 |
| K011798 | CORERESTORE 2 | Sybron Dental Specialties, Inc. | EBF | Class II | 2001-08-14 |
| K010118 | NORMED MANDIBULAR FIXATION SYSTEM | Osteomedics, Inc. | JEY | Class II | 2001-08-14 |
| K012213 | GULLIVER AND CLASSE A | American Dental Technologies, Inc. | EIA | Class I | 2001-08-13 |
| K012170 | DIGORA PCT | Soredex Palodex Group OY | MUH | Class II | 2001-08-10 |
| K010544 | VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE | Apex Dental Materials, Inc. | DYH | Class II | 2001-08-10 |
| K003714 | OSSTELL RESONANCE FREQUENCY ANALYZER | Integration Diagnostics, Ltd. | EKX | Class I | 2001-08-09 |
| K012355 | IMAGE-X SYSTEM | Tg Group, Inc. | EHD | Class II | 2001-08-09 |
| K011695 | COLLAGEN DENTAL MEMBRANE | Collagen Matrix, Inc. | NPL | Class II | 2001-08-07 |
| K011822 | PIT AND FISSURE CHEMICAL CURING SEALANT | Rite-Dent Manufacturing Corp. | EBC | Class II | 2001-08-07 |
| K012134 | GC E-LIGHT | GC America, Inc. | EBZ | Class II | 2001-08-07 |
| K003281 | LACTOSORB RAPIDFLAP | Biomet, Inc. | JEY | Class II | 2001-08-07 |
| K993124 | DISPODRILL | Kis Products | KOJ | Class II | 2001-08-06 |
| K002790 | ADD-ON CONDYLE | Walter Lorenz Surgical, Inc. | NEI | Class II | 2001-08-06 |
| K984380 | DISPO ETCH | Kis Products | KOJ | Class II | 2001-08-06 |
| K011666 | CHILLIT | Heatshield, Inc. | EAT | Class II | 2001-08-06 |
| K993182 | DISPOPROPHY | Kis Products | KOJ | Class II | 2001-08-06 |
| K011706 | FLEXICAST PRIME | American Dent-All, Inc. | EJH | Class II | 2001-08-06 |
| K011705 | SUPREMCAST | American Dent-All, Inc. | EJH | Class II | 2001-08-03 |
| K011748 | FIRST FILL R.C.S. | Jeneric/Pentron, Inc. | KIF | Class II | 2001-08-03 |
| K012299 | MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM | Basic Dental Implant Systems, Inc. | DZE | Class II | 2001-08-01 |
| K011521 | ORTHO VLC; ORTHO VLC CAPSULE | First Scientific Limited | DYH | Class II | 2001-08-01 |
| K011685 | BISTITE II DC | Tokuyama America, Inc. | EMA | Class II | 2001-07-31 |
| K010541 | PREVISION CHEM | Heraeus Kulzer, Inc. | EMA | Class II | 2001-07-31 |
| K012060 | MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT | Hu-Friedy Mfg. Co., Inc. | ELC | Class II | 2001-07-27 |
| K990667 | KLS-MARTIN TEMPORARY CONDYLAR IMPLANT | KLS-Martin L.P. | NEI | Class II | 2001-07-27 |
| K011520 | RESTORE-X | First Scientific Limited | EMA | Class II | 2001-07-23 |
| K010415 | ISODAN | Specialites Septodont | KLE | Class II | 2001-07-23 |
| K011453 | TOOTH SHADE RESIN MATERIAL | Rite-Dent Manufacturing Corp. | EBF | Class II | 2001-07-23 |
| K011452 | CAVEX STABISIL | Cavex Holland BV | ELW | Class II | 2001-07-19 |
| K011756 | ADMIRA FLOW | Voco GmbH | EBF | Class II | 2001-07-18 |
| K011628 | CONCORD 82 | Gateway Alloys, Inc. | EJT | Class II | 2001-07-16 |
| K011626 | CONCORD 72 | Gateway Alloys, Inc. | EJT | Class II | 2001-07-16 |
| K011419 | CAVEX COLORCHANGE | Cavex Holland BV | ELW | Class II | 2001-07-16 |
| K003045 | HA-TI (HAND TITANIUM SCREW) IMPLANT | Hati Dental Ag. | DZE | Class II | 2001-07-12 |
| K011560 | TRUBYTE DENTURE BASE RESIN SYSTEM | Dentsply Intl. | EBI | Class II | 2001-07-12 |
| K002207 | MACROPOREPX PEDIATRIC SYSTEM | Macropore Biosurgery, Inc. | JEY | Class II | 2001-07-11 |
| K011517 | LUTE; CORE | First Scientific Limited | EBF | Class II | 2001-07-10 |
| K003818 | TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS | Titan Implants | DZE | Class II | 2001-07-05 |
| K011130 | PREMIUM | Heraeus Kulzer, Inc. | ELM | Class II | 2001-07-05 |
| K011492 | IN TEN-S | Ivoclar North America, Inc. | EBF | Class II | 2001-07-05 |
| K011032 | SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA | Harvest Technologies, Corp. | LYC | Class II | 2001-07-03 |
| K011394 | LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM | Espe Dental AG | EIH | Class II | 2001-06-29 |
| K011619 | PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT | Planmeca Oy | EHD | Class II | 2001-06-29 |
| K010139 | ZURICH DISTRACTION SYSTEM | KLS-Martin L.P. | MQN | Class II | 2001-06-29 |
| K011061 | SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11 | W&H Dentalwerk Buermoos GmbH | EGS | Class I | 2001-06-28 |
| K011295 | RESTORE-PF VIC; RESTORE-PF VLC CAPSULE | First Scientific Limited | EBF | Class II | 2001-06-27 |
| K011490 | MODIFICATION TO EXCITE | Ivoclar North America, Inc. | KLE | Class II | 2001-06-27 |
| K011277 | HARD RELINER | S & C Polymer GmbH | EBI | Class II | 2001-06-26 |
| K010957 | QUELL DESENSITIZER | Jeneric/Pentron, Inc. | LBH | Class II | 2001-06-25 |
| K011245 | ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM | Sulzer Dental, Inc. | DZE | Class II | 2001-06-25 |
| K011222 | PORTABELL, MODEL 4200 | Bell Dental Products, LLC | EIA | Class I | 2001-06-25 |
| K011331 | JP CAST 40 | Jeneric/Pentron, Inc. | EJT | Class II | 2001-06-22 |
| K011330 | JP CAST 50 | Jeneric/Pentron, Inc. | EJT | Class II | 2001-06-22 |
| K011675 | THE AUTOTAC SYSTEM | BioHorizons Implant Systems, Inc. | DZL | Class II | 2001-06-22 |
| K011309 | LUTE VLC; CORE VLC | First Scientific Limited | EBF | Class II | 2001-06-22 |
| K010940 | SEALAPEX 4 | Sybron Dental Specialties, Inc. | KIF | Class II | 2001-06-20 |
| K011211 | FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW | Dmg USA, Inc. | EBF | Class II | 2001-06-18 |
| K011200 | GILB, MODEL 8010 | 3M Company | EMA | Class II | 2001-06-14 |
| K011450 | SILICONE IMPRESSION MATERIAL | Northeast Resins & Silicones, LLC | ELW | Class II | 2001-06-13 |
| K010775 | BIOCELLECT | Imtec Corp. | LYC | Class II | 2001-06-12 |
| K011431 | RESIN CEM | S & C Polymer GmbH | EMA | Class II | 2001-06-11 |
| K011159 | ONE-STEP PLUS | Bisco, Inc. | EMA | Class II | 2001-06-08 |
| K003517 | OTRES TOOTHBRUSH SANITIZER MODEL TB100W | Otres, LLC | MCF | Class I | 2001-06-06 |
| K011428 | TRICERAM | Dentaurum, Inc. | EIH | Class II | 2001-06-05 |
| K011179 | DELDENT ULTRASONIC INSERTS | Deldent , Ltd. | ELC | Class II | 2001-06-05 |
| K011425 | CARMEN | Dentaurum, Inc. | EIH | Class II | 2001-06-05 |
| K010701 | MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER | Medtronic Sofamor Danek USA, Inc. | LYC | Class II | 2001-06-05 |
| K010800 | VERSYO.COM | Heraeus Kulzer, Inc. | EBI | Class II | 2001-05-31 |
| K011362 | GOLD CORE 73 LS | Jeneric/Pentron, Inc. | EJT | Class II | 2001-05-29 |
| K010915 | CDMX | Camsight Co., Inc. | MUH | Class II | 2001-05-21 |
| K011028 | SCREW-VENT DENTAL IMPLANT SYSTEM | Sulzer Dental, Inc. | DZE | Class II | 2001-05-21 |
| K010690 | SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR | Synthes (Usa) | DZL | Class II | 2001-05-18 |
| K011167 | XSE | 3M Company | KLE | Class II | 2001-05-17 |
| K011064 | CLASSIC CEM | S & C Polymer GmbH | EMA | Class II | 2001-05-17 |
| K002037 | LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS | Lifecore Biomedical, Inc. | DZE | Class II | 2001-05-16 |
12,679 clearances in the Dental panel. Data: openFDA.