meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
43
Latest Decision
2006-06-26

Clearances · page 50 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K061427 PRE-IMPRESSION CONDITIONING SOLUTION Dentsply Intl. ELW Class II 2006-06-26
K051573 TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) Dr. Howard Martin, P.A. EKM Class I 2006-06-26
K061395 CALSET COMPOSITE HEATER Addent, Inc. EBZ Class II 2006-06-23
K061169 ENDOSSEOUS DENTAL IMPLANT Northern Implants, LLC DZE Class II 2006-06-20
K060500 SPEEDY ORTHODONTIC SCREW Dentium Co., Ltd. DZE Class II 2006-06-16
K060501 IMPLANTIUM II Dentium Co., Ltd. DZE Class II 2006-06-16
K060946 CZ-S2000 Parkell, Inc. KIF Class II 2006-06-15
K061341 PALMLIGHT 10, MODEL 001-00030 CAO Group, Inc. EBZ Class II 2006-06-12
K060691 EASY X-TRAC SYSTEM A. Titan Instruments, Inc. EMG Class I 2006-06-12
K053172 UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE) Owandy Sas MUH Class II 2006-06-09
K052493 SOCKET GRAFT Steiner Laboratories LYC Class II 2006-06-09
K061337 WIEDENT ESTETIC Xpdent Corp ELM Class II 2006-06-07
K061244 MUCOGRAFT Ed. Geistlich Soehne AG Fuer Chemische Industrie NPL Class II 2006-06-06
K061114 WDS, SIZE 2 AND SIZE 2 Cefla S.C.R.L. MUH Class II 2006-06-06
K060844 SILKLINE SOFT RELINING KIT, MODEL 28-100100 J. Morita USA, Inc. EBI Class II 2006-06-06
K060347 B&L L-BETA, MODEL WL-B1 B&L Biotech Co., Ltd. EKR Class I 2006-06-05
K061351 ORAL-B SONIC COMPLETE Braun GmbH JEQ Class I 2006-06-05
K060138 SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM Synthes (Usa) MQN Class II 2006-06-02
K051342 MEDICAL INTERPOROUS Bonyf AG EFT Class I 2006-06-02
K061322 PORCELAIN PRIMER J. Morita USA, Inc. KLE Class II 2006-06-02
K060744 O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE) O'Brien Dental Lab, Inc. LRK Class II 2006-06-02
K060732 MBCP GEL Biomatlante LYC Class II 2006-06-02
K052254 MYTIS ARROW XXXX Brainbase Corporation DZE Class II 2006-06-01
K053629 ANCHOR PLUS/NEO ANCHOR PLUS Kj Meditech DZE Class II 2006-05-31
K061199 ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES Braun GmbH JEQ Class I 2006-05-31
K061228 FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR Bryan Keropian Dds LQZ Class II 2006-05-26
K052271 RINSENDO Air Techniques, Inc. NYL Class I 2006-05-26
K060893 MODIFICATION TO REBILDA DC Voco GmbH EBF Class II 2006-05-25
K061264 TEMPFX ESTHETIC PROVISIONAL SYSTEM Dentsply International, Inc. EBG Class II 2006-05-23
K061175 CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES Sota Precision Optics, Inc. EIA Class I 2006-05-23
K060530 SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302. Lifecore Biomedical, Inc. ELL Class II 2006-05-22
K060994 MONDIAL Heraeus Kulzer, Inc. ELM Class II 2006-05-22
K060063 LEGACY ABUTMENT SYSTEM Implant Direct, LLC NHA Class II 2006-05-19
K060860 TURKOM-CERA Dental Suppliers of America, Inc. EIH Class II 2006-05-19
K060122 SLEEP SPLINT Nakagawa Dental Clinic LRK Class II 2006-05-19
K053166 SINCLAIR ORAL RINSE Sinclair Pharmaceuticals Limited NTO Class II 2006-05-17
K060388 TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT Airway Management, Inc. LRK Class II 2006-05-17
K060880 ZIMMER DENTAL ONE PIECE TAPERED ABUTMENT, MODELS TAC1, TACW1, TA5C1 Zimmer Dental, Inc. NHA Class II 2006-05-17
K061177 PROVIDE TEMPORARY CYLINDER Implant Innovations, Inc. NHA Class II 2006-05-16
K060126 ABSOANCHOR MICROIMPLANT Dentos, Inc. DZE Class II 2006-05-16
K060881 TEMPORARY CROWN & BRIDGE RESIN Cosmedent, Inc. EBG Class II 2006-05-16
K060701 BISCEM TRANSLUCENT, BISCEM OPAQUE Bisco, Inc. EMA Class II 2006-05-15
K060698 CEMENT-IT ALL PURPOSE, MODEL N97 Pentron Clinical Technologies EMA Class II 2006-05-10
K060565 CONDYLAFORM II NFC Ivoclar Vivadent, Inc. ELM Class II 2006-05-08
K060957 MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM Blue Sky Bio, LLC DZE Class II 2006-05-05
K060287 DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM W&H Dentalwerk Buermoos GmbH EBW Class I 2006-05-03
K060275 PIEZOTOME Satelec ELC Class II 2006-05-03
K060894 BIFIX QM Voco GmbH EMA Class II 2006-05-02
K060274 PIEZOTOME Satelec DZI Class II 2006-05-01
K060317 ANTHOGYR CONTRA ANGLES AND HANDPIECES Est. Anthogyr EGS Class I 2006-04-28
K060472 PREMISE FLOWABLE Kerr Corporation EBF Class II 2006-04-28
K060920 VELSCOPE Led Medical Diagnostics, Inc. NXV Class II 2006-04-27
K060441 VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98 Vident EIH Class II 2006-04-27
K060377 DR DISPOSABLE PROPHY ANGLE MODEL H310 Dental Resources EGS Class I 2006-04-26
K060376 SIMPLER HA THREADED, ST 5002-8, SIT 5002-8, ST 5011-ST5014, ST 5021-24 Simpler Implant, Inc. DZE Class II 2006-04-25
K060684 ADPER PROMPT, ADPER PROMPT L-POP 3M Espe AG Dental Products KLE Class II 2006-04-24
K060640 DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM Dentamerica EHD Class II 2006-04-24
K060646 BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 Monitex Industrial Co., Ltd. EBZ Class II 2006-04-21
K053353 RESCUE IMPLANT SYSTEM Megagen Co., Ltd. DZE Class II 2006-04-19
K060750 STRYKER INJECTABLE CEMENT Stryker Cmf NEA Class II 2006-04-19
K060177 KLS MARTIN RIGID FIXATION - STERILE KLS Martin L.P. JEY Class II 2006-04-18
K060365 APEXCAL Ivoclar Vivadent, Inc. EJK Class II 2006-04-17
K060892 GALILEOS Sirona Dental Systems GmbH MUH Class II 2006-04-14
K053354 INTERMEZZO PLUS FIXTURE Megagen Co., Ltd. DZE Class II 2006-04-13
K060837 IN-OVATION C Dentsply International NJM Class II 2006-04-10
K060270 MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL Linvatec Corp. DZI Class II 2006-04-10
K060507 VALPLAST YAMAHACHI TEETH Valplast Intl. Corp. ELM Class II 2006-04-07
K060492 AESCULAP CRANIOFACIAL PLATE AND SCREW Aesculap, Inc. JEY Class II 2006-04-07
K051798 OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEM Osteomed LP DZE Class II 2006-04-07
K060330 SEE-IT CARIES DETECTOR Ronvig Dental Mfg. A/S LFC Class II 2006-04-07
K053478 ENDOSSEOUS DENTAL IMPLANT SYSTEM Northern Implants, LLC DZE Class II 2006-04-05
K052515 SIROENDO Sirona Dental Systems GmbH EKX Class I 2006-03-31
K060075 FIBER-METAL POST Foremost Dental, LLC ELR Class I 2006-03-30
K052122 BISCO LED Bisco, Inc. EBZ Class II 2006-03-29
K060171 CLEANSE S+ ULTRASONIC SCALER Dmetec.Co., Ltd. ELC Class II 2006-03-29
K053368 INTERPROXIMAL REDUCTION SYSTEM Dentsply International EFB Class I 2006-03-29
K060332 ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY Isotis NV NUN Class II 2006-03-29
K060469 OPTIBOND ALL-IN-ONE Sybron Dental Specialties, Inc. KLE Class II 2006-03-28
K060306 ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY Isotis NV NUN Class II 2006-03-27
K053384 FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM Astra Tech, Inc. DZE Class II 2006-03-24
K051953 EVERSTICK A&O Stick Tech , Ltd. DYW Class II 2006-03-21
K051719 A.B. DENTAL DEVICES A.B. Dental Devices , Ltd. DZE Class II 2006-03-21
K060285 BONEGEN - TR Bio-Lok Intl., Inc. LYC Class II 2006-03-16
K060637 DENFIL FLOW Vericom Co., Ltd. EBF Class II 2006-03-16
K060328 PLANMECA PROMAX 3D Planmeca Oy MUH Class II 2006-03-15
K060104 PRISMATIK CLINICAL ZIRCONIA Glidewell Laboratories EIH Class II 2006-03-15
K053355 BTI INTERNA DENTAL IMPLANT SYSTEM B.T.I. Biotechnology Institute, Sl. DZE Class II 2006-03-14
K060178 VIX WIN PRO Gendex Dental Systems MUH Class II 2006-03-10
K052800 PROVISIONAL INLAY/ONLAY KIT Dmg USA, Inc. EBG Class II 2006-03-07
K060086 FENIIIIIIX COLORATION KIT Dental Arte, Inc. EIH Class II 2006-03-03
K053450 ATLANTIS ABUTMENT FOR ZIMMER INTERFACE Atlantis Components, Inc. NHA Class II 2006-03-03
K060292 KODAK MODELS 2100 AND 2200 Kodak-Trophy EHD Class II 2006-03-03
K053619 COLORBITE Zhermack S.P.A. ELW Class II 2006-03-01
K053088 SLACTIVE IMPLANTS Institut Straumann AG DZE Class II 2006-02-27
K050586 LEONE IMPLANT SYSTEM Leone S.P.A. DZE Class II 2006-02-27
K060291 PREFORMANCE TEMPORARY CYLINDER Implant Innovations, Inc. NHA Class II 2006-02-27
K060334 GI DENTSTAT Ultradent Products, Inc. EMA Class II 2006-02-23
K053068 PROCERA BRIDGE LAMINATE, MODEL 40-4002 Nobel Biocare AB NHA Class II 2006-02-22
K053050 PROCERA BRIDGE ALUMINA Nobel Biocare AB NHA Class II 2006-02-22
K053260 OSSIX -PLUS Colbar Lifescience , Ltd. NPL Class II 2006-02-22

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