meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
34
Latest Decision
2003-12-02

Clearances · page 57 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K033201 LA500 BLUE LIGHT Apoza Enterprise Co., Ltd. EBZ Class II 2003-12-02
K033553 PFZ PORCELAIN SYSTEM Dentsply Intl. EIH Class II 2003-12-02
K032774 RENOVA INTERNAL HEX IMPLANT SYSTEM Lifecore Biomedical, Inc. DZE Class II 2003-11-26
K033597 ATR 5000, LC 5000, IMPLANT SYSTEM Advanced Technology Research (A.T.R.) S.R.L. EKX Class I 2003-11-25
K033117 GRANDIO FLOW Voco GmbH EBF Class II 2003-11-25
K033022 PROTEMP 3 GARANT 3M Espe AG Dental Products EBG Class II 2003-11-21
K030644 CONTEC DUO, CONTEC LC, CONTEC LCR Dentaurum DYH Class II 2003-11-21
K032995 SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL) Micron Corp. ELC Class II 2003-11-20
K032708 PLASTALGIN AND PLASTALGIN ORTHO Septodont ELW Class II 2003-11-20
K032543 SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES Sirona Dental Systems GmbH EIA Class I 2003-11-14
K033446 APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 We Dong Myung Dental Industrial Co., Ltd. EJT Class II 2003-11-13
K031793 DENTATUS OSCIOMAT Dentatus USA , Ltd. DZH Class II 2003-11-13
K032921 PREMISE Sybron Dental Specialties, Inc. EBF Class II 2003-11-13
K033435 E-SARANG 86, DM78, DM55 We Dong Myung Dental Industrial Co., Ltd. EJT Class II 2003-11-12
K032520 ORTRAUTEK TRAUMA SYSTEM Tekka JEY Class II 2003-11-12
K031494 DOC'S BEST WHITE COPPER CEMENT Cooley & Cooley, Ltd. EMA Class II 2003-11-12
K033434 BESTALOY We Dong Myung Dental Industrial Co., Ltd. EJJ Class II 2003-11-12
K032607 POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 Linvatec Corp. DZI Class II 2003-11-10
K033430 3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615 Implant Innovations, Inc. DZE Class II 2003-11-07
K032455 PANAVIA F 2.0 Kuraray Medical, Inc. EMA Class II 2003-11-07
K032470 MULTILINK Ivoclar Vivadent, Inc. EMA Class II 2003-11-05
K031073 PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE Novabone Products, LLC LYC Class II 2003-11-05
K032597 BISCEM GI Bisco, Inc. EMA Class II 2003-11-04
K033346 SPI EASY DENTAL IMPLANT PROTECTIVE CAP Thommen Medical AG NHA Class II 2003-11-03
K032662 GUTTAFLOW Coltene/Whaledent GmbH & Co. KG KIF Class II 2003-11-03
K031708 OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM Osteomed LP MQN Class II 2003-11-03
K033068 IONOFIL COLOR AC Voco GmbH EMA Class II 2003-10-31
K033194 INION CPS BABY 1.5 BIOABSORBABLE SYSTEM Inion , Ltd. JEY Class II 2003-10-30
K031681 STERISIL ANTIMICROBIAL TUBING AND BOTTLE Sterisil EIA Class I 2003-10-30
K031341 STICK FLOW Stick Tech , Ltd. EBF Class II 2003-10-29
K033065 SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES Synthes (Usa) MQN Class II 2003-10-29
K032442 KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II KLS-Martin L.P. MQN Class II 2003-10-29
K033295 BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN Novamin Technology, Inc. LBH Class II 2003-10-28
K031989 ORTRAUTEK ORTHOGNATHIC SYSTEM Tekka JEY Class II 2003-10-28
K033221 KAVO EVEREST ZH-BLANK Kavo America Corporation EIH Class II 2003-10-28
K032099 SWISS MASTER LIGHT (Ems Sa) Electro Medical Systems EBZ Class II 2003-10-27
K033049 CZR PRESS Noritake Co., Inc. EIH Class II 2003-10-24
K032392 MORALES PROTRACTION FACEMASK Ortosim, S.A. DE C.V. DZB Class II 2003-10-22
K032351 THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT BioHorizons Implant Systems, Inc. DZE Class II 2003-10-21
K032465 MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI Satelec EBZ Class II 2003-10-21
K033248 HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM Hitachi Medical Systems America, Inc. MUH Class II 2003-10-20
K033121 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES Synthes (Usa) JEY Class II 2003-10-20
K033243 ITI SYNOCTA MESO ABUTMENTS Straumann USA NHA Class II 2003-10-20
K032289 FIT CHECKER II GC America, Inc. ELW Class II 2003-10-20
K032395 PROPHY-MATE Nakanishi, Inc. EFB Class I 2003-10-17
K030922 VIVASENS Ivoclar Vivadent, Inc. LBH Class II 2003-10-17
K032408 DAMON FT Sybron Dental Specialties, Inc. DYW Class II 2003-10-15
K032904 ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 Dentsply Intl. EIA Class I 2003-10-14
K033073 ORTHOPHOS XG DS/CEPH Sirona Dental Systems GmbH EHD Class II 2003-10-10
K033160 SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES Synthes (Usa) JEY Class II 2003-10-09
K032175 DESENS-IONOMER Milton Hodosh, M.D. EMA Class II 2003-10-09
K024105 VELOPEX AQUACUT FLUID ABRASION UNIT Velopex International, Inc. KOJ Class II 2003-10-09
K032605 METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING Meta Biomed Co., Ltd. KIF Class II 2003-10-08
K032195 DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT Dentaurum DYH Class II 2003-10-07
K032603 METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING Meta Biomed Co., Ltd. KIF Class II 2003-10-07
K032407 OPTIBAND LC Sybron Dental Specialties, Inc. DYH Class II 2003-10-06
K032140 5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM Innova Life Sciences Corp. DZE Class II 2003-10-02
K032750 MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE Friandent GmbH DZE Class II 2003-10-02
K031439 ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR) Harry J. Bosworth Co. ELW Class II 2003-10-02
K032302 XIVE TG ABUTMENTS Friadent GmbH DZE Class II 2003-10-02
K032234 MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K Mk-Dent GmbH EFB Class I 2003-10-02
K022505 CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068, NOUVAG AG EGS Class I 2003-10-01
K032320 APPOLLO 3 ALLOY Dentsply International EJT Class II 2003-10-01
K032116 TULIP COLORSWITCH Cavex Holland BV ELW Class II 2003-09-30
K032316 ORION E ALLOY Dentsply Intl. EJT Class II 2003-09-30
K032319 CERA R PLUS ALLOY Dentsply International EJT Class II 2003-09-30
K032318 MINERVA 58 ALLOY Dentsply International EJT Class II 2003-09-30
K032321 CERA F ALLOY Dentsply International EJT Class II 2003-09-30
K032317 ORION GX ALLOY Dentsply Intl. EJT Class II 2003-09-30
K032042 ENVISION Sybron Dental Specialties, Inc. DYH Class II 2003-09-29
K032892 MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM Dentsply Intl. EBI Class II 2003-09-26
K032851 ULTRACROWN 75 ALLOY Dentsply International EJT Class II 2003-09-26
K032715 DW 296 #15 SOLDER Ivoclar Vivadent, Inc. EJT Class II 2003-09-26
K032355 ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW Dentsply Gendex EHD Class II 2003-09-25
K032773 DIAMOND D HIGH IMPACT DENTURE ACRYLIC Mycone Dental Supply Co., Inc. EBI Class II 2003-09-23
K032495 THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM Lifecore Biomedical, Inc. DZE Class II 2003-09-17
K032267 R&D DESIGNATION AP-052-5 Jensen Industries, Inc. EJT Class II 2003-09-17
K031632 OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS Implant Innovations, Inc. DZE Class II 2003-09-16
K032165 VINTAGE AL Shofu Dental Corp. EIH Class II 2003-09-16
K030614 3I DENTAL IMPLANTS Implant Innovations, Inc. DZE Class II 2003-09-15
K031932 FLUORIDE VARNISH Dentsply Intl. LBH Class II 2003-09-15
K031801 PANTOS, MODELS: PANTOS 16, AND PANTOS DG Blue X Imaging Srl MUH Class II 2003-09-11
K022258 B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM B.T.I. Biotechnology Institute, Sl. DZE Class II 2003-09-11
K031721 COMPOSITE RESTORATION MATERIAL Milton Hodosh, M.D. EBF Class II 2003-09-11
K031659 UNIVERSAL NEURO SYSTEM Stryker Instruments JEY Class II 2003-09-10
K030790 OSTEOMED ALVEOLAR DISTRACTION SYSTEM Osteomed LP MQN Class II 2003-09-10
K032179 COMP. E Parkell, Inc. KLE Class II 2003-09-09
K031811 PIT & FISSURE SEALANT WITH FLUORIDE Harry J. Bosworth Co. EBC Class II 2003-09-04
K032493 ALEXANDER Ivoclar Vivadent, Inc. EJT Class II 2003-09-04
K032136 WIROBOND C Bego U.S.A. EJH Class II 2003-09-04
K031761 SYNTHES (USA) NEW/STERIAL ORBITAL PLATES Synthes (Usa) JEY Class II 2003-09-03
K023722 SAFETYWAND DISPOSABLE HANDPIECE Spintech, Inc. EJI Class II 2003-09-02
K032070 ELCACAM A-Dec, Inc. EIA Class I 2003-08-27
K032498 DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM) Straumann USA NHA Class II 2003-08-27
K030440 OASYS-ORAL AIRWAY SYSTEM Mark Abramson, D.D.S., Inc. LRK Class II 2003-08-26
K032106 STARBOND DENTAL BONDING ALLOYS Star Refining Precious Metals South Africa EJT Class II 2003-08-25
K030977 DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE Dentaurum DYH Class II 2003-08-25
K030980 DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE Dentaurum DYH Class II 2003-08-25
K024250 MATCH PRESS PRESSABLE CERAMIC Davis Schottlander & Davis, Ltd. EIH Class II 2003-08-25
K032341 INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 Sota Precision Optics, Inc. EIA Class I 2003-08-25

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