meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
34
Latest Decision
1998-07-31

Clearances · page 73 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K980990 POLYCARBOXYLATE CEMENT Medental Intl. EMA Class II 1998-07-31
K982148 PRODIGY 2 Sybron Dental Specialties, Inc. EBF Class II 1998-07-31
K981562 SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT Sulzer Calcitek, Inc. EBF Class II 1998-07-30
K981618 LIQUID A Harry J. Bosworth Co. EMA Class II 1998-07-28
K973636 MCS-MEDICATED CANAL SEALER Dr. Howard Martin, P.A. EMA Class II 1998-07-27
K972817 RESOR-PIN RESORBABLE MEMBRANE PIN Geistlich-Pharma LYC Class II 1998-07-24
K981534 VIPERCAM Integra Medical EIA Class I 1998-07-23
K982094 VERABOND 2 Aalba Dent, Inc. EJH Class II 1998-07-22
K982007 TRUBYTE DENTURE BOND DENTURE BONDING AGENT Dentsply Intl. KLE Class II 1998-07-22
DEN980003 DIAMOND PROBE/PERIO 2000 SYSTEM Diamond General Development Corp. MVH Class II 1998-07-17
K981459 MEMBRANE TACK Biomet, Inc. DZL Class II 1998-07-14
K981813 PERMACEM AUTOMIX LUTING CEMENT SYSTEM Foremost Dental Mfg., Inc. EBF Class II 1998-07-10
K981524 PRILANE Gresco Products, Inc. EIH Class II 1998-07-10
K981965 FLOWABLE COMPOSITE Dentsply Intl. EMA Class II 1998-07-10
K974655 PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM Prep Technology Corp. KOJ Class II 1998-07-09
K981182 OSTEOGRAF/N-300 Ceramed Dental, LLC LYC Class II 1998-07-02
K981335 ARISTON PHC LINER Ivoclar North America, Inc. EMA Class II 1998-07-02
K981264 ARISTON PHC Ivoclar USA, Inc. EBF Class II 1998-07-02
K981247 SILCAST (CODE NAME RD-0118) J.F. Jelenko & Co., Inc. EJS Class II 1998-07-01
K981362 SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR Synthes (Usa) DZL Class II 1998-06-29
K981214 OSTEOGRAF/N-700 Ceramed Dental, LLC LYC Class II 1998-06-26
K981461 GC FUJI ORTHO LC GC America, Inc. DYH Class II 1998-06-25
K981433 ORTHODONTIC BRACES Midwest Orthodontic Mfg. DYW Class II 1998-06-25
K981275 SYNTHES (USA) RATCHETING DISTRACTOR Synthes (Usa) MQN Class II 1998-06-25
K982009 ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE Scitech Solutions, Inc. EIA Class I 1998-06-25
K981990 MRS-400, MAXI 400, MRSL-400, MAXI 400L D.B.I. America Corp. EFB Class I 1998-06-22
K981075 SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET Synthes (Usa) MQN Class II 1998-06-22
K981448 KERR HARD DENTURE RELINE MATERIAL Sybron Dental Specialties, Inc. EBI Class II 1998-06-16
K981383 ALLOYBOND Southern Dental Industries, Inc. KLE Class II 1998-06-16
K980216 KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6 Kreativ, Inc. KOJ Class II 1998-06-16
K981202 WATER FILLED GUM SOOTHER Corium Corp. KKO Class II 1998-06-16
K981514 GC FUJI BOND LC GC America, Inc. KLE Class II 1998-06-16
K974761 BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH John O. Butler Co. EFW Class I 1998-06-16
K981390 ODONTOSURGE 2 Periogiene EKZ Class II 1998-06-11
K981325 3M M.G. MATERIAL 3M Company ELW Class II 1998-06-11
K980983 THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Biomedics JEY Class II 1998-06-09
K980968 LONE STAR IMPRESSION SYSTEMS Lone Star Technologies ELW Class II 1998-06-09
K973201 PROVI CEMENT S & C Polymer GmbH EMA Class II 1998-06-05
K980162 MACH-SIGMA HANDPIECE, ULTRAPUSH Nsk Nakanishi, Inc. EFB Class I 1998-06-05
K980927 LACTOSORB PANELS AND FASTENERS Biomet, Inc. JEY Class II 1998-06-05
K981234 FLARE,FILE, FILL Lone Star Technologies EJB Class I 1998-06-05
K981370 MIRACLE MIX CAPSULE GC America, Inc. EMA Class II 1998-06-01
K974106 ICON IMPLANT SYSTEM Bio Science Technologies, Inc. DZE Class II 1998-06-01
K980952 SNORE-CURE ANTI-SNORING APPLIANCE ORTHO-TAIN, Inc. LRK Class II 1998-06-01
K974123 BRANEMARK SYSTEM DEC 600 DRILLING UNIT Nobel Biocare Uas, Inc. DZE Class II 1998-05-26
K974488 AIRPREP SYSTEM - MODEL 9001 Asi Medical, Inc. KOJ Class II 1998-05-26
K981091 NEOCOLLOID, ORTHOPRINT Zhermack S.P.A. ELW Class II 1998-05-21
K981070 20-HOLE ADAPTATION PLATE Biomet, Inc. JEY Class II 1998-05-20
K980842 COPPER TONGUE SCRAPER Ontel Products Corp. LCN Class I 1998-05-20
K980018 CRISTOBAL Newave Medical, Inc. EBF Class II 1998-05-19
K981001 ORION VESTA DENTAL ALLOY European Dental Imports, Inc. EJS Class II 1998-05-18
K981002 ORION WX DENTAL ALLOY European Dental Imports, Inc. EJS Class II 1998-05-18
K980620 DENTATUS MTI MODULAR TRANSITIONAL IMPLANTS AND PROSTHETIC SYSTEM Dentatus USA , Ltd. DZE Class II 1998-05-15
K981000 CARRARA PORCELAIN AND CARRARA VINCENT PORCELAIN European Dental Imports, Inc. EIH Class II 1998-05-15
K980792 CU-100A LIGHT CURE UNIT Rolence Enterprise Co. , Ltd. EBF Class II 1998-05-15
K980793 Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT Rolence Enterprise Co. , Ltd. EBF Class II 1998-05-15
K980726 ULTRA-BLASTER Ultradent Products, Inc. KOJ Class II 1998-05-12
K980963 HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES) Foremost Dental Mfg., Inc. ELW Class II 1998-05-11
K980986 PROCAD Ivoclar USA, Inc. EIH Class II 1998-05-11
K980512 LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW Walter Lorenz Surgical, Inc. JEY Class II 1998-05-11
K981516 STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB Sterngold/Implamed DZE Class II 1998-05-11
K980577 PRINCESS SYRINGE Sodexco EIA Class I 1998-05-08
K973924 FRIOS BONESHIELD Friatec AG JEY Class II 1998-05-07
K980460 ONPLANT ORTHODONTIC SYSTEM Nobel Biocare Uas, Inc. DZE Class II 1998-05-05
K980965 SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL Cavex Holland BV ELW Class II 1998-05-01
K980661 CERA E DENTAL ALLOY European Dental Imports, Inc. EJS Class II 1998-05-01
K974649 BIO-POST DENTAL POST SYSTEM Advanced Aeromedical, Inc. ELR Class I 1998-05-01
K980633 ENDOSOLV E Specialites Septodont KIF Class II 1998-05-01
K980922 PROTEC CEM. Ivoclar North America, Inc. EMA Class II 1998-04-30
K980568 JUMBO GLASS IONOMER CEMENT Centrix, Inc. EMA Class II 1998-04-30
K980616 PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15) Kohler Medizintechnik GmbH & Co. KG EBI Class II 1998-04-30
K980549 OSSEOTITE DENTAL IMPLANT SYSTEM Implant Innovations, Inc. DZE Class II 1998-04-28
K980058 TOKUSO MAC BOND II Tokuyama America, Inc. EBF Class II 1998-04-27
K980054 PALFIQUE ESTELITE Tokuyama America, Inc. EBF Class II 1998-04-27
K980436 CLASS III REVERSE PULL FACEMASK Ortho Kinetics Corp. DZB Class II 1998-04-27
K980660 BIOGOLD PLUS DENTAL ALLOY European Dental Imports, Inc. EJT Class II 1998-04-27
K980245 NITOM LOCKING FACEBOW Ortho Kinetics Corp. DZB Class II 1998-04-21
K980783 SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 Irt Management Corp. KHR Class I 1998-04-21
K980864 POWER COINS GLOW IN THE DARK LIGATURES Ortho Kinetics Corp. ECI Class I 1998-04-20
K980581 PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM Planmeca Oy EHD Class II 1998-04-17
K980199 SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS Synthes (Usa) DZL Class II 1998-04-17
K980543 DENOPTIX BARRIER ENVELOPE (SIZE 0-4) Dentsply Intl. EHD Class II 1998-04-14
K980695 FUJI I GC America, Inc. EMA Class II 1998-04-13
K980474 TELICAM Dental/Medical Diagnostic Systems, Inc. EIA Class I 1998-04-13
K974097 PERIACRYL Blacklock Medical Products, Inc. EMA Class II 1998-04-09
K980159 OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01 Closure Medical Corp. EMA Class II 1998-04-09
K980151 RELEASABLE FORCE MODULE Ortho Kinetics Corp. DZB Class II 1998-04-06
K980682 FUJI II GC America, Inc. EMA Class II 1998-04-03
K980679 ENDOBON Biomet, Inc. LYC Class II 1998-04-03
K974877 CRANEX TOME CEPH, OR CRANEX TOME Orion Corporation Soredex EHD Class II 1998-03-27
K974737 ASTRA TECH IMPLANT DENTAL SYSTEM Astra Tech, Inc. DZE Class II 1998-03-24
K974828 BRANEMARK SYSTEM(R) EBON(TM) FIXTURE Nobel Biocare Uas, Inc. DZE Class II 1998-03-24
K974906 ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM Coltene/Whaledent, Inc. KLE Class II 1998-03-24
K980539 SOLOBOND M Voco GmbH KLE Class II 1998-03-23
K973548 MERCURY DENTAL Aleaciones Dentales Zeyco, S.A. DE C.V. ELY Class II 1998-03-23
K973002 HURRISEAL DENTIN DESENSITIZER Cheng & Assoc., Inc. KLE Class II 1998-03-23
K974202 PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS Pulpdent Corp. LBH Class II 1998-03-19
K980698 ASTRA TECH IMPLANTS - DENTAL SYSTEM Astra Tech, Inc. DZE Class II 1998-03-19
K980439 REPLACE CYLINDRICAL IMPLANTS Steri-Oss, Inc. DZE Class II 1998-03-16
K980442 CRYSTAL AND CRYSTAL-SEAL IMPLANTS SYSTEM Crystal Medical Technology DZE Class II 1998-03-16

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