meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
43
Latest Decision
1988-07-01

Clearances · page 108 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K881903 PROSTHODENT VL Lee Pharmaceuticals EBF Class II 1988-07-01
K881091 OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL Coe Laboratories, Inc. ELW Class II 1988-06-28
K882309 THE DIRECTION DIAL Lawhorn Innovations EKJ Class I 1988-06-23
K882135 AQUA DENT HANDPIECE EXTENSION AND AQUA DENT DISP. Vita Dental Co. EFB Class I 1988-06-22
K882399 ASEPTIP Koppa Innovative Dental Products, Inc. EKJ Class I 1988-06-21
K882183 DENTAL BURS Tri-Stage, Inc. EJL Class I 1988-06-21
K875212 PXS MODEL PXS7-730EA DENTAL X-RAY SOURCE Kevex Corp. EHD Class II 1988-06-17
K882170 RX ASPEN Jeneric/Pentron, Inc. EJH Class II 1988-06-17
K880791 MAXIMUM CURE SEALANT Reliance Orthodontic Products, Inc. DYH Class II 1988-06-13
K881924 ENDOSSEOUS DENTAL IMPLANT Bone Anchorage Systems, Inc. DZE Class II 1988-06-13
K882098 DENTORIDGE(TM) HYDROXYYLAPATITE Norian Corp. LYC Class II 1988-06-13
K882006 CLEARFIL PHOTO CORE Kuraray Co. EBF Class II 1988-06-13
K873437 BIONIC-TOOTH-PLANT MODEL A-1 Larry R. Ashkinazy, D.D.S. DZE Class II 1988-06-13
K882063 MAGNE-DENT MAGNET/ZEST RETROFIT KEEPER Zest Anchors, Inc. EGG Class I 1988-06-13
K882126 JEL-5 GOLD BASED ALLOYS & PRECIOUS METAL ALLOYS J.F. Jelenko & Co., Inc. EJT Class II 1988-06-13
K880793 LIGHT BOND Reliance Orthodontic Products, Inc. DYH Class II 1988-06-13
K882164 FLOSS CARD Arthur Blank & Co., Inc. JES Class I 1988-06-10
K875340 JETPOLISHER(TM) Young Dental Manufacturing Co. 1, LLC KOJ Class II 1988-06-10
K881661 IONOSCEM OR IONOSCELL GLASS IONOMER DENTAL CEMENT Specialites Septodont EMA Class II 1988-06-07
K881900 PERMA-PIC PLASTIC TOOTHPICK The Perma-Pic Co. JET Class I 1988-06-01
K880250 KERR XR BOND Kerr Corporation (Danbury) EMA Class II 1988-06-01
K881789 MINILINE BRACKET Alexotek Co. EJF Class I 1988-06-01
K881860 OLYMPIA II J.F. Jelenko & Co., Inc. EJT Class II 1988-06-01
K881026 CONTAC, A DENTIN SEALANT Harry J. Bosworth Co. LBH Class II 1988-06-01
K881861 PTM-45 J.F. Jelenko & Co., Inc. EJT Class II 1988-06-01
K880251 KERR XR IONOMER Kerr Corporation (Danbury) EMA Class II 1988-06-01
K874396 OCO PREPARATIONS Williams Importing Company, Inc. EJF Class I 1988-05-18
K880774 SPECTRUM Dentsply Intl. ELL Class II 1988-05-18
K880848 FUJI CAP II CAPSULE & APPLIER G-C Intl. Corp. EMA Class II 1988-05-16
K881046 SUPER PIK MASSAGING PICK FOR ORAL HYGIENE U.S. Dentek Corp. JET Class I 1988-05-13
K880754 DRI-CLAVE LIQUID KLEENZALL Columbus Dental Mfg. Co. EHZ Class I 1988-05-12
K880993 AMALGAMATOR Acecodent, Inc. EFD Class I 1988-05-11
K880684 XR PRIMER Kerr Corporation (Danbury) KLE Class II 1988-05-11
K880589 ROTA-DENT TOOTH CLEANER Pro-Dentec JEQ Class I 1988-05-11
K874590 INNOVATIVE IMPLANTS AND COVER SCREWS Implant Innovations International, Inc. DZE Class II 1988-05-11
K880849 EXAMIX DISPENSER G-C Intl. Corp. EKJ Class I 1988-05-11
K880348 PALLADIUM-BASED DENTAL ALLOYS FOR PORCELAIN APPLI. J.F. Jelenko & Co., Inc. EJT Class II 1988-05-11
K880685 PORCELITE DUAL CURE CEMENT Kerr Corporation (Danbury) EMA Class II 1988-05-11
K880956 SNOAR(TM) OPEN AIRWAY APPLIANCE Kent J. Toone, D.D.S. LQZ Class II 1988-05-11
K880485 XENEX DENTAL ROULETTE G & A Industries, Inc. EFW Class I 1988-05-02
K880542 DENTALVISION TV SYSTEM Dentsply Intl. EKJ Class I 1988-05-02
K880209 PERIODONTAL PROBE - AUTOPROBE Dentsply Intl. EIL Class I 1988-04-27
K880766 RELIANCE METAL PRIMER Reliance Orthodontic Products, Inc. DYH Class II 1988-04-25
K881333 OLYMPIA ALLOY J.F. Jelenko & Co., Inc. EJJ Class II 1988-04-21
K881331 ORTHODONTIC NITINOL SPRINGS Flexmedics EJW Class I 1988-04-21
K881253 ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW Dentalez Group ELC Class II 1988-04-21
K880765 G-CERA PORCELAIN BOND G-C Intl. Corp. EBF Class II 1988-04-18
K880790 PORCELAIN PRIMER Reliance Orthodontic Products, Inc. DYH Class II 1988-04-18
K880621 CAPCADDY Capcad, Inc. EJI Class II 1988-04-18
K880792 PLASTIC PRIMER Reliance Orthodontic Products, Inc. DYH Class II 1988-04-18
K875339 JETPOLISHER AIRPOLISHING POWDER Young Dental Manufacturing Co. 1, LLC EJR Class I 1988-04-18
K881354 RAJAH J.F. Jelenko & Co., Inc. EJT Class II 1988-04-18
K881274 CENTER BEND ARCH WIRES Flexmedics EJF Class I 1988-04-12
K880764 G-CERA PORCELAIN & G-CERA PORCELAIN MODIFIER G-C Intl. Corp. ELL Class II 1988-04-12
K881233 STRAIGHT LENGTH ARCH WIRES Flexmedics EJF Class I 1988-04-12
K880827 ACCUTEK PERIODONTAL PROBE Sweet Micro Systems, Inc. EIX Class I 1988-04-12
K874788 KETAC-BOND APLICAP Espe GmbH (Us) EMA Class II 1988-04-12
K880882 REVERSE CURVE ARCHWIRE Flexmedics EJF Class I 1988-04-11
K880875 VITALLIUM EQUIPOISE ALLOY Austenal Dental, Inc. EJH Class II 1988-04-07
K881163 RECTANGULAR NITINOL ARCH WIRE Flexmedics EJF Class I 1988-04-07
K880392 ORTHOLUX VISIBLE LIGHT CURING UNIT Unitek Corp. EBZ Class II 1988-04-07
K881139 THERMAFIL ENDODONTIC OBTURATOR Tulsa Dental Products, Ltd. EKM Class I 1988-04-07
K872825 AXIAL TOME, 60, FLUORO AND TOMAX Axialtome Corp. EHD Class II 1988-03-31
K880393 TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE Unitek Corp. DYH Class II 1988-03-31
K880220 TRI-STAGE (TS-I) DENTAL IMPLANT Tri-Stage, Inc. DZE Class II 1988-03-31
K880607 UTILITY WAX STRIPS, SPEARMINT Columbus Dental Mfg. Co. EGD Class I 1988-03-31
K880606 UTILITY WAX STRIPS, CINNAMON Columbus Dental Mfg. Co. EGD Class I 1988-03-24
K874228 BOND FAST NO MIX ADHESIVE Advanced Orthodontics Systems, Inc. DYH Class II 1988-03-18
K875255 DREAM DAM Dental Dam, Inc. EIE Class I 1988-03-18
K875351 DEN-MAT PORETCH (PORCELAIN ETCHANT) Den-Mat Corp. ELL Class II 1988-03-18
K875344 HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY Kulzer, Inc. EJJ Class II 1988-03-18
K874308 JEL-62 Jelenko Co. EJT Class II 1988-03-18
K874458 PRIME PLUS-POLYACRYLIC ACID BOND CONDITIONER Lustgarten Multi-Tech International, Inc. EMA Class II 1988-03-18
K873939 ADI/B/*/HA-2 STAGE OSSEO. HYDRO. DENTAL IMPLANT Anchor Implants , Ltd. DZE Class II 1988-03-15
K873255 THE MICRO-VENT/HA Core-Vent Corp. DZE Class II 1988-03-14
K875313 PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST Bisco, Inc. EBF Class II 1988-03-10
K875076 FLORIDA PROBE Florida Probe Corp. EIX Class I 1988-03-10
K880179 BEAVERS' DENTAL DIAMOND INSTRUMENTS Beavers Dental, Div. Sybron Canada, Ltd. DZP Class I 1988-03-09
K875228 PERMADYNE ADHESIVE Espe GmbH (Us) EBH Class I 1988-03-09
K872984 KETAC-CONDITIONER Espe GmbH (Us) EMA Class II 1988-03-09
K875257 IMPREGUM F ADHESIVE Espe GmbH (Us) EBH Class I 1988-03-09
K880068 EFFERVESCENT DENTURE CLEANSER Perrigo Co. EFT Class I 1988-03-07
K873739 ACRYLIC IMPRESSION TRAY MATERIALS E&D Dental Manufacturing Co. EBH Class I 1988-03-07
K880033 DEGUSTAR Degussa Dental, Inc. EJT Class II 1988-03-07
K880590 DISPOSABLE DENTAL PROBE/EXPLORER Baxter Healthcare Corp EKJ Class I 1988-03-02
K872588 CLEARFIL PHOTO POSTERIOR Kuraray Co. EBF Class II 1988-03-02
K874400 NON-ROTATING GOLD CYLINDER AND SCREW Implant Innovations International, Inc. DZE Class II 1988-03-02
K875133 CAVIT-W Espe GmbH (Us) EBG Class II 1988-03-01
K875142 PHASE II Reliance Orthodontic Products, Inc. DYH Class II 1988-02-29
K875091 ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT Mission White Dental, Inc. EBC Class II 1988-02-29
K875242 DB PRECISION IMPLANT SYSTEM, 1000 SERIES W/HAC Driskell Bioengineering DZE Class II 1988-02-26
K875256 BISCOLOR Bisco, Inc. EBF Class II 1988-02-26
K875145 MAR BOND Reliance Orthodontic Products, Inc. EBG Class II 1988-02-26
K875243 DB PRECISION IMPLANT SYSTEM, 2000 SERIES W/HAC Driskell Bioengineering DZE Class II 1988-02-26
K873818 VENT CORP PIB IMPLANT Core-Vent Corp. DZE Class II 1988-02-26
K875141 EXCEL REGULAR SET Reliance Orthodontic Products, Inc. DYH Class II 1988-02-26
K875143 RELY-A-BOND(NO MIX ORTHODONTIC ADHESIVE) Reliance Orthodontic Products, Inc. DYH Class II 1988-02-26
K875144 EXCEL FAST SET Reliance Orthodontic Products, Inc. DYH Class II 1988-02-26
K873882 ALKALINER Espe GmbH (Us) EJK Class II 1988-02-26
K875150 PERIODONTAL SCALING SOLUTION-C Dentsply Intl. EFS Class I 1988-02-23

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