meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
35
Latest Decision
2005-05-19

Clearances · page 53 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K050705 TIUNITE IMPLANTS Nobel Biocare AB DZE Class II 2005-05-19
K050608 SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM Synthes (Usa) JEY Class II 2005-05-18
K050959 DELTON ILLUMINATING PIT AND FISSURE SEALING Dentsply International EBC Class II 2005-05-11
K050920 CZR PRESS LF STAINS Noritake Co., Inc. EIH Class II 2005-05-11
K050934 MODUS TITANIUM OSTEOSYNTHESIS SYSTEM Medartis, Inc. JEY Class II 2005-05-05
K050612 LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE Lightspeed Technology, Inc. EKX Class I 2005-05-04
K050393 THE GUIDED SURGERY CONCEPT Nobel Biocare AB DZE Class II 2005-05-04
K050838 THE LF-P CERAMIC SYSTEM Jensen Industries, Inc. EIH Class II 2005-05-04
K051077 E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 Aseptico, Inc. EGS Class I 2005-05-03
K041184 NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION Nti-Tss, Inc. LRK Class II 2005-05-03
K051010 SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 Septodont EJJ Class II 2005-05-02
K040501 DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX Musculoskeletal Transplant Foundation NUN Class II 2005-04-29
K043156 D-CARIE, MODEL N121-M1 Neks Technologies, Inc. NBL Class II 2005-04-28
K050401 CERAMAGE Shofu Dental Corp. EBF Class II 2005-04-28
K050712 4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT Bicon, Inc. DZE Class II 2005-04-22
K050880 DYRACT EXTRA RESTORATIVE Dentsply Intl. EBF Class II 2005-04-22
K050895 SURPASSON P5 NEWTRON Satelec ELC Class II 2005-04-20
K050647 ALL-IN-ONE Bisco, Inc. KLE Class II 2005-04-20
K050258 GROOVY IMPLANTS Nobel Biocare AB DZE Class II 2005-04-19
DEN050001 DECAPINOL ORAL RINSE Sinclair Pharmaceuticals Limited NTO Class II 2005-04-18
K042965 TOMAS PIN Dentaurum, Inc. OAT Class II 2005-04-15
K050506 PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS Lifecore Biomedical, Inc. DZE Class II 2005-04-15
K050604 KERR VPS IMPRESSION MATERIAL Sybron Dental Specialties, Inc. ELW Class II 2005-04-15
K040757 SIC PRO Sic Invent AG DZE Class II 2005-04-13
K043555 SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR Synthes (Usa) MQN Class II 2005-04-12
K050408 BICON ORTHODONTIC IMPLANT SYSTEM Bicon, Inc. DZE Class II 2005-04-07
K050641 ZYGOMA TIUNITE Nobel Biocare USA, LLC NHA Class II 2005-04-07
K050606 SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL) Synthes (Usa) DZL Class II 2005-04-06
K050750 LC BRACKET ADHESIVE SYSTEM Dentsply Intl. DYH Class II 2005-04-06
K050515 BONE BLOCK FIXATION SET Straumann USA, Inc. DZL Class II 2005-04-05
K041614 MICROLUX DL Addent, Inc. EAZ Class I 2005-04-04
K050730 MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM Ultradent Products, Inc. DYW Class II 2005-03-31
K050710 MINIMASTER ULTRASONIC SCALER E.M.S Electro Medical Systems S.A ELC Class II 2005-03-30
K050331 ADHESIVE 1 Southern Dental Industries, Inc. KLE Class II 2005-03-24
K042715 TITAN DENTAL IMPLANT ATTACHMENT Titan Implants, Inc. NHA Class II 2005-03-23
K043033 GLOBAL TREASURES FLUID FILLED TEETHER Global Treasure Industries , Ltd. KKO Class II 2005-03-22
K050354 PERIOSCAN ULTRASONIC SCALER Sirona Dental Systems GmbH ELC Class II 2005-03-21
K043497 AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV J. Morita USA, Inc. EFB Class I 2005-03-21
K050426 TEMPOSIL, MODEL 6720 Coltene/Whaledent AG EMA Class II 2005-03-18
K050201 AEU-14CF EXPENDITION Aseptico, Inc. EIA Class I 2005-03-18
K042972 XP TECHNOLOGY ULTRASONIC SCALER American Eagle Instruments, Inc. ELC Class II 2005-03-18
K050535 STRYKER MMF SCREW Stryker Instruments DZL Class II 2005-03-17
K050255 ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4 Gendex Dental Systems EHD Class II 2005-03-17
K050362 VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES) Vident EIH Class II 2005-03-15
K050378 SYNTHES MANDIBLE EXTERNAL FIXATOR Synthes (Usa) MQN Class II 2005-03-15
K043195 NEO IMPLANT SYSTEM Neoss, Ltd. DZE Class II 2005-03-07
K050052 ATLANTIS ABUTMENT FOR STRAUMANN INTERFACE Atlantis Components, Inc. NHA Class II 2005-03-07
K043493 FUSION PUTTY TYPE GC America, Inc. ELW Class II 2005-03-04
K050318 BARI-KAD PACKING DEVICE Bioenvelop Agro, Inc. EIE Class I 2005-03-04
K050204 SYNTHES RAPID RESORBABLE TACK SYSTEM Synthes (Usa) JEY Class II 2005-03-04
K050144 PRISMATIK CERAMIC Glidewell Laboratories EIH Class II 2005-03-03
K032410 SNORENTI James P Boyd LQZ Class II 2005-02-28
K043170 BOSWORTH BOND Harry J. Bosworth Co. KLE Class II 2005-02-25
K043104 KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0 Practiceworks, Inc. EHD Class II 2005-02-24
K050386 PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM Dentsply International KLE Class II 2005-02-23
K043297 MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM Medicon EG JEY Class II 2005-02-23
K043054 GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL Sultan Chemists, Inc. ELW Class II 2005-02-18
K043498 TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE J. Morita USA, Inc. EFB Class I 2005-02-16
K043496 SPACELINE EMCIA, MODEL CU580 J. Morita USA, Inc. EIA Class I 2005-02-16
K042730 CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G Lifecorebiomedical LYC Class II 2005-02-14
K050203 ALLUX Wieland Dental + Technik GmbH & Co. KG EIH Class II 2005-02-14
K043325 ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES Rolence Enteprise, Inc. EIA Class I 2005-02-11
K043434 OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM Osteomed LP MQN Class II 2005-02-10
K043612 ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D Instrumentarium Corp. Imaging Division EHD Class II 2005-02-09
K050013 RETRACTOFOAM Coltene/Whaledent AG ELW Class II 2005-02-09
K050160 KATANA ZIRCONIA Noritake Co., Inc. EIH Class II 2005-02-07
K050257 LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE) Mondeal Medical Systems GmbH DZE Class II 2005-02-07
K050059 G-LIGHT GC America, Inc. EBZ Class II 2005-02-03
K043168 BISCOVER LV Bisco, Inc. EBD Class II 2005-02-01
K043312 NOBELRONDO DENTAL CERAMIC - ZIRCONIA Nobel Biocare USA, LLC EIH Class II 2005-02-01
K042804 TESCERA OPAQUER POWDER/SCULPTING RESIN Bisco, Inc. EBF Class II 2005-02-01
K050019 IN EXAM INTRAORAL DENTAL X-RAY SYSTEM Kavo America EHD Class II 2005-01-31
K042278 ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) Oral Osteodistraction, L.P. MQN Class II 2005-01-28
K043504 PALAIMPACT Heraeus Kulzer, Inc. EBI Class II 2005-01-28
K043471 FUSION FAST GC America, Inc. ELW Class II 2005-01-27
K043530 DVI CURING LIGHT Designs For Vision, Inc. EBZ Class II 2005-01-25
K043301 GC TION GINGIVAL PROTECTOR GC America, Inc. EIE Class I 2005-01-25
K043118 HYDROGUM SOFT Zhermack S.P.A. ELW Class II 2005-01-24
K043472 MEDIN TECH ZIRCONIA-CP10, SS1000 Medin Tech EIH Class II 2005-01-18
K042971 TITAN DENTAL IMPLANT SYSTEM Titan Implants, Inc. DZE Class II 2005-01-14
K042345 LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) Mondeal Medical Systems GmbH DZE Class II 2005-01-13
K043226 ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 Imtec Corp. DZE Class II 2005-01-13
K043557 MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS Panoramic Corp. EHD Class II 2005-01-13
K043468 WILLI GELLER CREATION II PORCELAIN Jensen Int'L, Inc. EIH Class II 2005-01-12
K043462 CZR PRESS LF Noritake Co., Inc. EIH Class II 2005-01-11
K043201 WILLI GELLER CREATION ZI PORCELAIN Jensen Industries, Inc. EIH Class II 2005-01-11
K042870 ENDO TWINN Endo Twinn B.V. EKM Class I 2005-01-11
K043043 HERMES BOND 2 3M Espe AG Dental Products KLE Class II 2005-01-10
K043136 ELITY 70 X-RAY Dental X-Ray E.U. EHD Class II 2005-01-06
K043295 VERSYO.DIRECT Heraeus Kulzer, Inc. EBI Class II 2005-01-05
K043302 NOVA-PULSE Nova Ranger, Inc. EBZ Class II 2005-01-03
K043562 BC PLUS Vericom Co., Ltd. KLE Class II 2005-01-03
K043068 DIFOTI USB 2.0 SYSTEM Electro-Optical Sciences, Inc. NTK Class II 2004-12-29
K042822 TCM ENDO V, MODEL 1534 NOUVAG AG EKX Class I 2004-12-22
K043247 DUCERA ALLCERAM Dentsply Intl. EIH Class II 2004-12-22
K033044 DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER American Green Dent. Mfg, Inc. ELC Class II 2004-12-21
K043221 WILLI GELLER CREATION CP PORCELAIN Jensen Industries, Inc. EIH Class II 2004-12-20
K042846 SYSTEMP.LINK Ivoclar Vivadent, Inc. EMA Class II 2004-12-20
K042787 IS 40 MICROMOTOR Satelec EFB Class I 2004-12-17
K042847 SYSTEMP.CEM Ivoclar Vivadent, Inc. EMA Class II 2004-12-17

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