meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
33
Latest Decision
1999-07-15

Clearances · page 70 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K990304 MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM Astra Tech, Inc. DZE Class II 1999-07-15
K991489 ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET) Harry J. Bosworth Co. ELW Class II 1999-07-15
K991114 REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM Lifecore Biomedical, Inc. DZE Class II 1999-07-14
K991450 ETCHING GEL Silicon-Und Composite Spezialitaten GmbH EBF Class II 1999-07-09
K991774 ACRON MC MODIFICATION GC America, Inc. EBI Class II 1999-07-09
K991808 OPTIBOND SOLO PLUS 2 Sybron Dental Specialties, Inc. KLE Class II 1999-07-09
K991711 BISTITE II SC Tokuyama America, Inc. EMA Class II 1999-07-07
K991098 DIFOTI SYSTEM Electro-Optical Sciences, Inc. EIA Class I 1999-06-30
K984508 SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD W&H Dentalwerk Buermoos GmbH DZA Class I 1999-06-25
K991053 ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO) Astra Tech, Inc. DZE Class II 1999-06-25
K991455 ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C, Trophy Radiologie EHD Class II 1999-06-25
K991035 QUANTEC-E IRRIGATION SYSTEM Sybron Dental Specialties, Inc. EIA Class I 1999-06-24
K991021 SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL Nsk Nakanishi, Inc. ELC Class II 1999-06-23
K991564 JELTEMP J.F. Jelenko & Co., Inc. EBG Class II 1999-06-23
K981141 SARGON IMMEDIATE LOAD IMPLANT, MODEL D Sargon Ent., Inc. DZE Class II 1999-06-23
K991011 ORASCOPE Fiberdent Corp. EIA Class I 1999-06-23
K991004 SYNTHES QUICK LOCK IMF SYSTEM Synthes (Usa) DYX Class II 1999-06-23
K991912 MODIFICATION TO DIGIPAN Trophy Radiologie EHD Class II 1999-06-22
K991488 SELF CURE COMPOSITE Harry J. Bosworth Co. EBF Class II 1999-06-21
K982951 IMTEC BIOPIN Imtec Corp. DZL Class II 1999-06-21
K991491 FLC COMPOSITE Harry J. Bosworth Co. EBF Class II 1999-06-21
K991518 PANATOME Imaging Sciences Intl., Inc. EHD Class II 1999-06-18
K991008 DIMENSION BITE Espe Dental AG ELW Class II 1999-06-18
K991310 EXPLOR-X 70 Villa Sistemi Medicali S.P.A. EHD Class II 1999-06-18
K984536 REMOVABLE CUFF ABUTMENT Sulzer Calcitek, Inc. DZE Class II 1999-06-16
K990944 OSTEOMED INTRAORAL DISTRACTION SYSTEM Osteomed Corp. MQN Class II 1999-06-16
K991425 XANTOPREN COMFORT Heraeus Kulzer, Inc. ELW Class II 1999-06-15
K990871 PILLOWPOSITIVE CERVICAL PILLOW Lifesleep Systems, Inc. MYB Class II 1999-06-10
K991099 AMERICAN DENTAL PRODUCTS ETCH-DETECT American Dental Products, Inc. EBC Class II 1999-06-10
K990846 AMORPHOUS DIAMOND COATED DRILL Nobel Biocare Uas, Inc. DZI Class II 1999-06-10
K990920 DRG TITANIUM BONE PLATE Doctor'S Research Group, Inc. JEY Class II 1999-06-10
K990954 ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET Nsk Nakanishi, Inc. EBW Class I 1999-06-09
K990743 SOLO ORTHO Sybron Dental Specialties, Inc. DYH Class II 1999-06-04
K991442 LC MICROFILL S & C Polymer GmbH EBF Class II 1999-06-03
K990736 GC RELINE SOFT/EXTRA SOFT GC America, Inc. EBI Class II 1999-05-28
K990844 STARDENTAL AXCS STERILE WATER SYSTEM Dentalez Group EIA Class I 1999-05-28
K990908 MILLENNIUM Endo Technic Corp. MXF Class II 1999-05-27
K990739 QUANTEC-E ENDO SYSTEM Sybron Dental Specialties, Inc. EKX Class I 1999-05-26
K990763 VITRON M Espe Dental AG EBI Class II 1999-05-25
K991270 SMARTEMP Parkell, Inc. EBG Class II 1999-05-21
K991220 VITRON H Espe Dental AG EBI Class II 1999-05-20
K991221 VESTOGUM Espe Dental AG ELW Class II 1999-05-20
K982925 LAMINOSS DENTAL IMPLANT Impladent , Ltd. DZE Class II 1999-05-18
K991172 IONOSIT BOND Dmg Chemisch Pharmazeutische Fabrik GmbH EMA Class II 1999-05-17
K990381 TOTALBOND Parkell, Inc. EMA Class II 1999-05-17
K990699 ORTHO-GLOW GLITTER Harry J. Bosworth Co. EBI Class II 1999-05-17
K990650 CONSEAL F Southern Dental Industries, Inc. EBC Class II 1999-05-14
K984104 ITI DENTAL IMPLANT SYSTEM Straumann USA DZE Class II 1999-05-13
K990087 DMD DIGITAL X-RAY SYSTEM Dental/Medical Diagnostic Systems, Inc. MUH Class II 1999-05-13
K990482 3M CLINPRO PROPHY PASTE, MODEL 12611 Minnesota Mining and Mfg. Co. EJR Class I 1999-05-13
K983728 LORENZ IMF SCREW Walter Lorenz Surgical, Inc. DZL Class II 1999-05-13
K990479 HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR Hygenitek, Inc. EIA Class I 1999-05-13
K991436 STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTRUMENTATION Sterngold DZE Class II 1999-05-07
K990756 FLOW LINE Heraeus Kulzer, Inc. EBF Class II 1999-05-07
K990344 ORALGIENE TONGUE CLEANER Oralgiene USA, Inc. LCN Class I 1999-05-04
K990528 ORTHOPHOS 3/3 CEPH/3 DS Sirona Dental Systems GmbH MUH Class II 1999-04-30
K991161 HYDRO-CAST ACRYLIC VARNISH, MODEL 78125 Kay See Dental Mfg. Co. EIA Class I 1999-04-29
K984332 SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTRAORAL CAMERA, SPECTRA VU HDDI SV I INTRAORAL CAMERA, International Technology Concepts EIA Class I 1999-04-29
K990511 X-TIP INTRAOSSEOUS PERFORATOR Schiff & Co. DZM Class I 1999-04-27
K990982 CAVIT LC Espe Dental AG EBF Class II 1999-04-23
K991138 LYSTA LC CURING LIGHT, MODEL LC 2500C/BA Lysta A/S EBZ Class II 1999-04-23
K990948 S575 INTRAORAL DOCKING DENTAL CAMERA Sopro EIA Class I 1999-04-21
K990367 PDQ AND PDQ-TI ABUTMENT Vident DZE Class II 1999-04-21
K983461 UNI-FLEX RESIN Trans-Atlantic Dental EBI Class II 1999-04-13
K990983 MODIFICATION TO IMTEC SENDAX MDI Imtec Corp. DZE Class II 1999-04-13
K990277 O-RING ABUTMENT BioHorizons Implant Systems, Inc. DZE Class II 1999-04-09
K990363 BIOMESH BIODEGRADABLE GTR BARRIER Samyang Corp. NPK Class II 1999-04-09
K990817 IPS D.SIGN PORCELAIN Ivoclar North America, Inc. EIH Class II 1999-04-06
K990898 PRODIGY 4 Sybron Dental Specialties, Inc. EBF Class II 1999-04-06
K981036 SMARTBOND Gac Intl., Inc. DYH Class II 1999-04-05
K990314 MULTI-CURE COMPOSITE CEMENT Medental Intl. EBF Class II 1999-04-02
K990670 HELIOFORM GOLD-BASED ALLOY C. Hafner GmbH & Co. EJT Class II 1999-04-02
K990790 VISION PORCELAIN Servo Dental USA, Inc. EIH Class II 1999-04-02
K990002 QUICKRAY DSX 730 Julie Alliance MUH Class II 1999-04-01
K984641 FLEXISCOPE OPTOMODUL Schoelly Fiberoptic GmbH EIA Class I 1999-03-29
K990140 NORMED BONE TRANSPORT Ace Surgical Supply Co., Inc. JEY Class II 1999-03-25
K990056 JELDENT MULTICRYL J.F. Jelenko & Co., Inc. EBI Class II 1999-03-25
K990682 PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) Nsk Nakanishi, Inc. EKX Class I 1999-03-24
K990448 THE.R.MO.FREE Dentamax, Inc. EBI Class II 1999-03-23
K981858 ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW Atlantis Components, Inc. DZE Class II 1999-03-22
K984584 AIR TECHNIQUES' DENTO-VAC Air Techniques, Inc. EIA Class I 1999-03-22
K990646 PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE Nsk Nakanishi, Inc. EKX Class I 1999-03-19
K990534 EXCITE Ivoclar North America, Inc. KLE Class II 1999-03-19
K990629 SYMBIOCERAM Ney Dental, Inc. EIH Class II 1999-03-19
K983360 MACROPORE PROTECTIVE SHEET Pacific Materials and Interfaces JEY Class II 1999-03-19
K984587 ALLROUND-E (CODE NAME RD 1710) J.F. Jelenko & Co., Inc. EJS Class II 1999-03-17
K984427 EXCELSIOR PORCELAIN SYSTEM Ney Dental, Inc. EIH Class II 1999-03-15
K983742 ITI DENTAL IMPLANT SYSTEM Institut Straumann AG DZE Class II 1999-03-15
K990049 CD-DENT DIGITAL IMAGING DEVICES FOR DENTAL X-RAY SYSTEMS, MODELS 600, 1000 AND 2000 Digident , Ltd. MUH Class II 1999-03-12
K990108 LC FLOWFILL S & C Polymer GmbH EBF Class II 1999-03-09
K990498 OPTIBOND SOLO PLUS Sybron Dental Specialties, Inc. KLE Class II 1999-03-08
K983105 CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01 Dentsply Midwest EJI Class II 1999-03-08
K990315 MONOPAQUE Ivoclar North America, Inc. EBF Class II 1999-03-04
K990306 HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025 Kay See Dental Mfg. Co. EBC Class II 1999-03-03
K984287 PROVISIONAL DENTAL IMPLANT SYSTEM Nobel Biocare Uas, Inc. DZE Class II 1999-03-01
K990235 D-SIGN VI (R&D PROJECT DW266#9) Ivoclar North America, Inc. EJH Class II 1999-03-01
K990182 D-SIGN V (R&D PROJECT DW267#17) Ivoclar North America, Inc. EJH Class II 1999-03-01
K984503 ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 Wallace A. Erickson & Co. KLE Class II 1999-02-26
K990143 GLUMA ONE BOND Heraeus Kulzer, Inc. KLE Class II 1999-02-25
K990252 SOLO PLUS ORTHO Sybron Dental Specialties, Inc. DYH Class II 1999-02-25

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