Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 33
- Latest Decision
- 2000-12-14
Clearances · page 66 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K002989 | PROCLUDE | Ortek Therapeutics, Inc. | EJR | Class I | 2000-12-14 |
| K000834 | CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO | Castellini S.P.A. | EFB | Class I | 2000-12-14 |
| K003660 | LEIBINGER NEURO CLIP SYSTEM | Stryker Instruments | JEY | Class II | 2000-12-12 |
| K000594 | LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE | Stryker Leibinger | JEY | Class II | 2000-12-08 |
| K002614 | ADVENT IMPLANT SYSTEM | Core-Vent Corp. | DZE | Class II | 2000-12-08 |
| K002798 | CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS | Codman & Shurtleff, Inc. | JEY | Class II | 2000-12-06 |
| K003037 | JEWEL CAST III | Jeneric/Pentron, Inc. | EJH | Class II | 2000-12-05 |
| K003039 | GOLD CORE II | Jeneric/Pentron, Inc. | EJH | Class II | 2000-12-05 |
| K003377 | FERMIT N PLUS | Ivoclar North America, Inc. | EBG | Class II | 2000-12-04 |
| K000846 | TKD SCALERS | Orasystems | ELC | Class II | 2000-12-04 |
| K002753 | SPARTAN A-10 | Spartan Ultrasonics, Inc. | ELC | Class II | 2000-12-04 |
| K003374 | FERMIT PLUS | Ivoclar North America, Inc. | EBG | Class II | 2000-12-04 |
| K003034 | COLTENE AURA COMPOMER RESTORATIVE SYSTEM | Coltene/Whaledent, Inc. | EBF | Class II | 2000-11-30 |
| K002708 | KAVO CORUND HANDPIECE 2013 | Kavo America | KOJ | Class II | 2000-11-28 |
| K003011 | SELF ETCH BONDING PRIMER | Jeneric/Pentron, Inc. | KLE | Class II | 2000-11-28 |
| K003373 | PROCAD ADD-ON | Ivoclar North America, Inc. | EIH | Class II | 2000-11-28 |
| K002991 | ZAP DUAL CURING LIGHT | Soft-Core Texas, Inc. | EBZ | Class II | 2000-11-28 |
| K003361 | RENEW LS-2 | Bisco, Inc. | EBF | Class II | 2000-11-28 |
| K003317 | RENEW LS-1 | Bisco, Inc. | EBF | Class II | 2000-11-21 |
| K002709 | RACE ENDODONTIC FILE | Amc General, Inc. | EFA | Class I | 2000-11-17 |
| K003007 | GALAXY | Sterngold | EJT | Class II | 2000-11-17 |
| K002935 | SYNTHES 1.5MM TI BROW LIFT SCREW | Synthes (Usa) | DZL | Class II | 2000-11-16 |
| K002620 | SURESMILE SYSTEM | Orametrix, Inc. | EIA | Class I | 2000-11-16 |
| K002993 | HERACERAM | J.F. Jelenko & Co., Inc. | EIH | Class II | 2000-11-16 |
| K002619 | NEWGEN SYSTEM | Stryker Instruments | JEY | Class II | 2000-11-16 |
| K003153 | SOLOBOND PLUS | Voco GmbH | KLE | Class II | 2000-11-15 |
| K002843 | SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 | Sultan Chemists, Inc. | EMA | Class II | 2000-11-15 |
| K002521 | SPARTAN MTS | Spartan Marketing Group | ELC | Class II | 2000-11-13 |
| K002693 | CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS) | Cbs Intl. B.V. | EBL | Class I | 2000-11-09 |
| K002475 | REPLACE TPS COATED IMPLANTS | Nobel Biocare Uas, Inc. | DZE | Class II | 2000-11-09 |
| K002062 | SAMSUNG 10DR IMPLANT SYSTEM | Samsung Sds Co., Ltd. | EHD | Class II | 2000-11-09 |
| K002502 | CERAM-PRIME | S & C Polymer GmbH | KLE | Class II | 2000-11-08 |
| K002904 | WILLI GELLER CREATION AND LF PORCELAIN | Jensen Industries, Inc. | EIH | Class II | 2000-11-06 |
| K002872 | R&D PROJECT DW271#11A | Ivoclar North America, Inc. | EJT | Class II | 2000-11-02 |
| K002374 | ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT | Straumann USA | DZE | Class II | 2000-11-01 |
| K002808 | ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY | Nordiska Dental AB | EJJ | Class II | 2000-10-31 |
| K002811 | ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY | Nordiska Dental AB | EJJ | Class II | 2000-10-31 |
| K002810 | ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY | Nordiska Dental AB | EJJ | Class II | 2000-10-31 |
| K002188 | SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D, | Core-Vent Corp. | DZE | Class II | 2000-10-30 |
| K003221 | HARALD NORDIN GLASSIX GLASS FIBER COMPOSITE DENTAL POST | Harald Nordin S.A | ELR | Class I | 2000-10-25 |
| K003219 | HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST | Harald Nordin S.A | ELR | Class I | 2000-10-25 |
| K001493 | DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 | Air Force, Inc. | EFS | Class I | 2000-10-25 |
| K001884 | DIRECT CROWN | Flexible Dimensions, LLC | EBG | Class II | 2000-10-25 |
| K002675 | MILLENNIUM EDITION 2000 ACCELERATED ELECTROFORMING SYSTEM | Product Development Industries, Inc. | EJT | Class II | 2000-10-25 |
| K002826 | EQUITY | Jensen Industries, Inc. | EJT | Class II | 2000-10-24 |
| K002423 | LACTOSORB PUSH SCREW | Biomet, Inc. | DZL | Class II | 2000-10-20 |
| K002581 | DURAGARD SODIUM FLUORIDE VARNISH | Sultan Dental Products, Ltd. | LBH | Class II | 2000-10-20 |
| K000696 | MACROPOREMX MANDIBULAR FIXATION SYSTEM | Macropore Biosurgery, Inc. | JEY | Class II | 2000-10-19 |
| K002566 | LUMALITE CURE LIGHT, MODEL 2100 | Lumalite, Inc. | EBZ | Class II | 2000-10-19 |
| K002645 | JEL BIOS PURE | J.F. Jelenko & Co., Inc. | EJT | Class II | 2000-10-19 |
| K003090 | MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM | Midmark Corp. | EIA | Class I | 2000-10-18 |
| K002168 | ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE | Ronvig Instruments, Ltd. | EJI | Class II | 2000-10-13 |
| K001719 | Q-LUX PLASMA 100 LIGHT CURE UNIT | Rolence Enterprise Co. , Ltd. | EBZ | Class II | 2000-10-10 |
| K002152 | TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION | KLS-Martin L.P. | MQN | Class II | 2000-10-10 |
| K000848 | TDK HANDPIECES | Orasystems | EFB | Class I | 2000-10-05 |
| K002879 | MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | Bioplate, Inc. | JEY | Class II | 2000-10-05 |
| K002387 | COMFORT CONTROL SYRINGE SYSTEM | Dentsply Intl. | EJI | Class II | 2000-09-28 |
| K002452 | 3M RELY X VENEER CEMENT TRY-IN PASTER | 3M Company | EMA | Class II | 2000-09-28 |
| K000847 | ORALUBE | Orasystems | EFB | Class I | 2000-09-27 |
| K002302 | SUPER 14 | Dental Alloy Products, Inc. | EJH | Class II | 2000-09-26 |
| K002793 | KETAC CEM U | Espe Dental AG | EMA | Class II | 2000-09-26 |
| K002300 | SUPER 6 | Dental Alloy Products, Inc. | EJH | Class II | 2000-09-26 |
| K002461 | HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT | Shofu Dental Corp. | EMA | Class II | 2000-09-26 |
| K002066 | FREEZER TEETHER | Cool Baby, Inc. | KKO | Class II | 2000-09-26 |
| K002322 | MODIFICATION TO PANAVIA F | Kuraray America, Inc. | EMA | Class II | 2000-09-18 |
| K994137 | ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE | Atrix Laboratories, Inc. | LYC | Class II | 2000-09-13 |
| K002301 | SUPER 12 | Dental Alloy Products, Inc. | EJH | Class II | 2000-09-08 |
| K002299 | SUPER 3 | Dental Alloy Products, Inc. | EJH | Class II | 2000-09-08 |
| K000643 | INPLANT ORTHODONTIC ANCHOR SYSTEM | Nobel Biocare Uas, Inc. | DZE | Class II | 2000-09-07 |
| K002432 | STRATO X | Villa Sistemi Medicali S.P.A. | EHD | Class II | 2000-09-01 |
| K002222 | RD-2104 | J.F. Jelenko & Co., Inc. | EJT | Class II | 2000-08-31 |
| K002048 | JBC OPAQUE AND GLITTER | J.B.C and Co. | EBI | Class II | 2000-08-30 |
| K001899 | IMPROVED TRY-IN GEL | Sybron Dental Specialties, Inc. | EBF | Class II | 2000-08-28 |
| K000983 | CERAMIX PORCELAIN SYSTEM | C-Mix | EIH | Class II | 2000-08-26 |
| K001560 | ODONTOSURGE 3 | Odonto-Wave | EKZ | Class II | 2000-08-24 |
| K002298 | SUPER 1 | Dental Alloy Products, Inc. | EJH | Class II | 2000-08-24 |
| K001598 | BIOBAR, IMPLANTABLE BIODEGRADABLE COLLAGEN MEMBRANE FOR GUIDED BONE REGENERATION | Col-Bar , Ltd. | LYC | Class II | 2000-08-22 |
| K001881 | IMPROVED ENLIGHT LV | Sybron Dental Specialties, Inc. | DYH | Class II | 2000-08-22 |
| K002086 | PRIMAFLOW | Dmg USA, Inc. | EBF | Class II | 2000-08-17 |
| K001823 | LINKMAX | GC America, Inc. | EMA | Class II | 2000-08-16 |
| K002041 | WILLI GELLER CREATION & AV PORCELAIN | Jensen Industries, Inc. | EIH | Class II | 2000-08-16 |
| K970569 | BIO-BLOCKS | Geistlich-Pharma | LYC | Class II | 2000-08-14 |
| K001655 | PERMLASTIC 2 | Kerr Corp. | ELW | Class II | 2000-08-10 |
| K002364 | PROTEMP H | Espe Dental AG | EBG | Class II | 2000-08-10 |
| K001914 | CLEARFIL REPAIR | Kuraray Company, Ltd. | KLE | Class II | 2000-08-10 |
| K001815 | DC ZIRKON | Austenal, Inc. | EIH | Class II | 2000-08-10 |
| K001799 | DC-TELL | Austenal, Inc. | EBF | Class II | 2000-08-10 |
| K001414 | KWIKKMODEL | R-Dental Dentalerzeugnisse GmbH | ELW | Class II | 2000-08-09 |
| K001913 | CLEARFIL ST OPAQUER | Kuraray Company, Ltd. | EBF | Class II | 2000-08-04 |
| K001878 | WATER PURIFIER | Waterclave, LLC | EIA | Class I | 2000-08-03 |
| K001928 | SIGMA | Instrumentarium Imaging, Inc. | MUH | Class II | 2000-08-02 |
| K992905 | CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM | Codman & Shurtleff, Inc. | JEY | Class II | 2000-08-01 |
| K001798 | DC TITAN | Austenal, Inc. | EJH | Class II | 2000-07-31 |
| K001445 | SMILIE PC | Julie Alliance | EIA | Class I | 2000-07-26 |
| K000580 | ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15 | KLS-Martin L.P. | MQN | Class II | 2000-07-24 |
| K001050 | CALCIJECT | Centrix, Inc. | EJK | Class II | 2000-07-21 |
| K001446 | LIGHT-CURED ORTHODONTIC BAND CEMENT | Scientific Pharmaceuticals, Inc. | DYH | Class II | 2000-07-21 |
| K001876 | TAKE 1 BITE | Sybron Dental Specialties, Inc. | ELW | Class II | 2000-07-21 |
| K001541 | MINICAM | Video Dental Concepts, Inc. | EIA | Class I | 2000-07-21 |
| K001530 | THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM | Bioplate, Inc. | JEY | Class II | 2000-07-21 |
12,679 clearances in the Dental panel. Data: openFDA.