meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
38
Latest Decision
1999-11-17

Clearances · page 69 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K992822 SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE Dentsply Intl. LBH Class II 1999-11-17
K990779 HEMASEAL & CIDE Advantage Dental Products, Inc. LBH Class II 1999-11-17
K993344 P10 SPECIAL North American Alloys, Inc. EJH Class II 1999-11-15
K992838 ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE Biomat Sciences, Inc. KLE Class II 1999-11-15
K993488 LIGHT-CORE Bisco, Inc. EBF Class II 1999-11-10
K993324 CARBOCEM ZINC POLYCARBOXYLATE CEMENT Scientific Pharmaceuticals, Inc. EMA Class II 1999-11-09
K992879 ECUSIT COMPOSITE REPAIR Dmg Hamburg KLE Class II 1999-11-09
K990546 DELSONIC 2000 Sds Dental, Inc. ELC Class II 1999-11-05
K992001 TRAY-LINK Silicon-Und Composite Spezialitaten GmbH ELW Class II 1999-11-02
K992623 MITEK MINI ANCHOR Mitek Products DZL Class II 1999-11-02
K993223 RAPICURE 200 (CURING AND WHITENING LIGHT) Mediphotonix, LC EBZ Class II 1999-11-01
K992512 ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COA Imcor DZE Class II 1999-11-01
K992649 ATD AUTOMATIC BRIDGE REMOVER J. Morita USA, Inc. EIS Class I 1999-10-29
K993192 ILLUSION Bisco, Inc. EBF Class II 1999-10-27
K992097 ENDOREZ Ultradent Products, Inc. KIF Class II 1999-10-26
K993173 GOLD CORE 55 Jeneric/Pentron, Inc. EJT Class II 1999-10-26
K993175 GOLD CORE 75 Jeneric/Pentron, Inc. EJT Class II 1999-10-26
K991696 STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM Stryker Instruments DZI Class II 1999-10-25
K992519 NRC NON-RINSE CONDITIONER Dentsply Intl. EBC Class II 1999-10-22
K990637 SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD Synthes (Usa) NEI Class II 1999-10-22
K992629 D/SENSE II (GREEN-OR) DENTIN DESENSITIZER Centrix, Inc. LBH Class II 1999-10-22
K992582 PACIFIC IMPLANT TITANIUM ENDODONTIC POINT Pacific Implant, Inc. EKL Class I 1999-10-21
K993152 JEL BIOS 18 (CODE NAME RD- 1214) J.F. Jelenko & Co., Inc. EJT Class II 1999-10-21
K993136 JEL BIOS 10 (CODE NAME RD-1801) J.F. Jelenko & Co., Inc. EJT Class II 1999-10-21
K991239 VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2 Micron Corp. ELC Class II 1999-10-18
K992416 PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE Usbiomaterials Corp. LYC Class II 1999-10-15
K992435 BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER Azo Enterprises EFW Class I 1999-10-15
K992985 GLUMA COMFORT BOND Heraeus Kulzer, Inc. KLE Class II 1999-10-14
K992380 ENDO-EZE MOTOR AND HANDPIECE Ultradent Products, Inc. EFB Class I 1999-10-13
K992334 ENDOSSEOUS IMPLANTS AND ABUTMENTS- TIN COATING Implant Innovations, Inc. DZE Class II 1999-10-08
K992195 QUANTEC-E IRRIGATION SYSTEM 2 Sybron Dental Specialties, Inc. EIA Class I 1999-10-08
K992326 3M CLINPRO SEALANT 3M Company EBC Class II 1999-10-08
K992966 REFERENCE Espe Dental AG EBF Class II 1999-10-07
K991687 MODIFICATION TO LINER II: SOFT RELINE LIQUID Bosworth Co. EBI Class II 1999-10-07
K991857 AIRFLOW HANDY Electro Medical Systems, Inc. EFB Class I 1999-10-07
K992956 LUCITONE FRS FLEXIBEL DENTAL RESIN Dentsply Intl. EBI Class II 1999-10-06
K992292 GLUMA COMFORT BOND + DESENSITIZER Heraeus Kulzer, Inc. KLE Class II 1999-10-01
K984415 S.S. WHITE TECHNOLOGIES, MODELS 6500-D,6500-E, AND 6500-F S.S. White Technologies, Inc. KOJ Class II 1999-09-29
K984201 DENZIR Dentronic AB EIH Class II 1999-09-29
K992728 SPRING POWERLITE 2000 Spring Health Products, Inc. EBZ Class II 1999-09-29
K991947 3I CERAMIC ABUTMENT SYSTEM Implant Innovations, Inc. DZE Class II 1999-09-29
K993188 ENDOSTEPPER 1 Phytron- Elektronik GmbH EKX Class I 1999-09-28
K992385 ORTHOPANTOMOGRAPH OP100D Instrumentarium Corp. MUH Class II 1999-09-28
K992270 MIRACLEBREATH TONGUE CLEANER Stellar Labs, Inc. LCN Class I 1999-09-23
K992705 CERADIUM NON-PRECIOUS CERAMIC ALLOY Matech, Inc. EJH Class II 1999-09-22
K992161 CERANA Nordiska Dental AB EIH Class II 1999-09-22
K992609 HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 Kay See Dental Mfg. Co. EBI Class II 1999-09-22
K991577 NIC TONE ACRYLIC RESINS Manufacturera Dental Continental EBI Class II 1999-09-22
K991209 ORAL SLEEP DISORDER AID Perl-Rad Sleep Disorder Lab LRK Class II 1999-09-22
K992645 SINFONY Espe Dental AG EBF Class II 1999-09-22
K992518 PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM Dentsply Intl. EBC Class II 1999-09-22
K991974 FUTURA GLASS IONOMER SILVER REINFORCED Ab Ardent EMA Class II 1999-09-17
K992873 LORENZ EXTERNAL MANDIBULAR DISTRACTOR Walter Lorenz Surgical, Inc. MQN Class II 1999-09-17
K990212 LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00 Doctor'S Research Group, Inc. DYX Class II 1999-09-14
K992011 SYNEA-HS HIGH SPEED-HANDPIECE A-Dec, Inc. EFB Class I 1999-09-10
K992893 DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE Mrlb Intl., Inc. EIA Class I 1999-09-08
K992897 IMPREGUM PENTA Espe Dental AG ELW Class II 1999-09-08
K992895 IMPREGUM F Espe Dental AG ELW Class II 1999-09-08
K991996 IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR Denplus, Inc. EBI Class II 1999-09-08
K992868 DENTAPURE DP40 CARTRIDGE Mrlb Intl., Inc. EIA Class I 1999-09-07
K992610 GENDEX 765DC, MODEL 110-0154 Dentsply Intl. EHD Class II 1999-09-07
K991901 BIO-97 Jeneric/Pentron, Inc. EJT Class II 1999-09-07
K990979 STECO-TITANMAGNETICS Steco-System-Technik GmbH & Cokg EGG Class I 1999-09-03
K991946 ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L Sterilex Corp. EIA Class I 1999-09-03
K992023 GRAND CERAM Noritake Co., Inc. EIH Class II 1999-09-03
K991923 SOOTHE-N-SEAL CANKER SORE RELIEF Closure Medical Corp. MZW Class II 1999-09-02
K991948 DR. B'S MOUTHPIECE, MODEL 32129-10002 Snore - Ezzer LRK Class II 1999-09-02
K992102 LUMA LIGHT 2000 CURE LIGHT Lumalite, Inc. EBF Class II 1999-08-31
K992357 EASY-CURE (CURING AND WHITENING LIGHT) Ics of North America, Inc. EBZ Class II 1999-08-30
K992024 SUPER PORCELAIN TI-22 Noritake Co., Inc. EIH Class II 1999-08-27
K992236 LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA Lysta A/S EBZ Class II 1999-08-27
K981677 REPOSE BONE SCREW SYSTEM Influence, Inc. LRK Class II 1999-08-27
K992067 BELLEGLAZE Kerr Dental Materials Center EBD Class II 1999-08-27
K992516 DYRACT SEAL COMPOMER PIT & FISSURE SEALANT Dentsply Intl. EBC Class II 1999-08-27
K992248 POST CEMENT HI-X Bisco, Inc. EBF Class II 1999-08-25
K991888 MINIJECT Spartan Ultrasonics, Inc. EJI Class II 1999-08-25
K992644 SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM Sirona Dental Systems GmbH MUH Class II 1999-08-23
K991909 DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT Dentsply Intl. EBC Class II 1999-08-20
K992158 LACTOSORB SHEETS Biomet, Inc. JEY Class II 1999-08-20
K992118 PRODIGY 4 TRANSLUCENT SHADES Sybron Dental Specialties, Inc. EBF Class II 1999-08-18
K991875 K-L-W INTRAORAL DISTRACTOR KLS-Martin L.P. MQN Class II 1999-08-18
K992160 NEXUS 2 Sybron Dental Specialties, Inc. EMA Class II 1999-08-18
K991283 DYNA TORQ TORQUE WRENCH, TORQUE WRENCH Micro Motors, Inc. DZE Class II 1999-08-18
K992048 MODIFICATION OF PROMPT L-POP Espe Dental AG KLE Class II 1999-08-16
K991481 PARAGON Lancer Orthodontics, Inc. EJJ Class II 1999-08-11
K990545 JETSONIC 2000 Sds Dental, Inc. KOJ Class II 1999-08-11
K991701 MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD) Nsk Nakanishi, Inc. EFB Class I 1999-08-10
K991961 3M LVR SYSTEM 3M Company EBF Class II 1999-08-09
K991874 EMS SURFACE MOUNT SCALER (Ems Sa) Electro Medical Systems ELC Class II 1999-07-30
K983120 BICORTICAL SCREW Oraltronics Marketing-Und Vertriebs GmbH DZE Class II 1999-07-29
K991913 PENTAMIX 2 Espe Dental AG EFD Class I 1999-07-26
K991631 FASTRAY LC Harry J. Bosworth Co. ELW Class II 1999-07-26
K992216 BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE Integra Lifesciences Corp. LYC Class II 1999-07-26
K991902 LC PIT & FISSURE SEALANT Bosworth Co. EBC Class II 1999-07-26
K991449 SNORE-AID PLUS Dental Imagineers, LLC LRK Class II 1999-07-22
K991844 PRO-GLASS Cad Cam Ventures EIH Class II 1999-07-21
K991865 Q-LITE 75 LIGHT CURE UNIT Rolence Enterprise Co. , Ltd. EBZ Class II 1999-07-20
K990342 SYNOCTA PROSTHETICS Straumann USA DZE Class II 1999-07-20
K991863 CUTE-LITE I LIGHT CURE UNIT Rolence Enterprise Co. , Ltd. EBZ Class II 1999-07-19
K991490 ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET) Harry J. Bosworth Co. ELW Class II 1999-07-15

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