meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
34
Latest Decision
1996-06-05

Clearances · page 80 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K960900 IMCOR 3.75 MM WIDE HEX SELF-TAPPING SCREW W/COVER SCREW Imcor DZE Class II 1996-06-05
K954513 ACE SREW DENTLA IMPLANT SYSTEM Ace Surgical Supply Co., Inc. DZE Class II 1996-06-05
K962031 QUANTEC SERIES 2000 ENDODONTIC FILES Tycom Dental EKS Class I 1996-06-04
K961660 TONGUE CLEANER Jack Conrey LCN Class I 1996-05-31
K961708 LIFE AND LIFE FAST SET Sybron Dental Specialties, Inc. EJK Class II 1996-05-30
K960956 STERNGOLD M-PF YELLOW CROWN & BRIDGE ALLOY MODEL 1127200 Sterngold/Implamed EJT Class II 1996-05-29
K961291 FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS Dentsply Intl. EIH Class II 1996-05-28
K961198 BOSWORTH CH I Harry J. Bosworth Co. EBG Class II 1996-05-24
K961584 FUJI II LC (IMPROVED) GC America, Inc. EMA Class II 1996-05-24
K961417 GC FUJI ORTHO GC America, Inc. DYH Class II 1996-05-24
K960022 OPTI-MAX BODY DIAMETER W/5MM TOP W/EXTERNAL HEX, EXTERNALLY THREADED DENTAL IMPLANT COARSE THREADS Opti-Max DZE Class II 1996-05-24
K960945 IMZ MEMBRANE TACK SYSTEM Interpore Intl. DZL Class II 1996-05-24
K961158 SUPRASSON P5 BOOSTER Satelec ELC Class II 1996-05-23
K955646 VICRYL PERIDONTAL MESH ETHICON, Inc. NPK Class II 1996-05-20
K955703 NEO DENTAL ENDODONTIC IRRIGATION SYRINGE Neodental Chemical Products Co., Ltd. KIF Class II 1996-05-20
K960979 SCREW EXTRACTION DEVICE AND THREAD CLEANING TAP Steri-Oss, Inc. DZE Class II 1996-05-20
K961352 285 SL Argen Precious Metals, Inc. EJT Class II 1996-05-20
K961200 BOSWORTH LIQUID RESIN II Harry J. Bosworth Co. EBI Class II 1996-05-17
K961201 BOSWORTH IMPRESSION MATERIAL II Harry J. Bosworth Co. ELW Class II 1996-05-17
K960954 KETAC-MOLAR APLICAP Espe GmbH & Co. Kg. EMA Class II 1996-05-16
K960639 ABUTMENT SELECTION KIT Nobelpharma USA, Inc. DZE Class II 1996-05-14
K960889 SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS San Diego Swiss Machining, Inc. ELC Class II 1996-05-10
K960799 ORTHO-ICE Ultimate Wireforms, Inc. EAT Class II 1996-05-09
K960673 OSAP Snorefree, Inc. LQZ Class II 1996-05-09
K961284 KOLOR + Sybron Dental Specialties, Inc. EBF Class II 1996-05-08
K960556 BACSTOP DENTAL ANTI-RETRACTION CHECK VALVE Scitech Solutions, Inc. EIA Class I 1996-05-08
K960697 ULTRACID AND ULTRACID F DISINFECTING SOLUTION Ultradent Products, Inc. KLE Class II 1996-05-06
K961005 SARGON IMMEDIATE LOAD IMPLANT Graham & James DZE Class II 1996-05-06
K955332 OPTI-MAX EXTERNALLY THREADED CYLINDRICAL INTERNAL BORE DENTAL IMPLANT, WITH HEALING SCREW Opti-Max DZE Class II 1996-05-06
K955573 OPTIBLAST INTRAORAL SANDBLASTER Buffalo Dental Mfg. Co., Inc. KOJ Class II 1996-05-03
K960594 LIGHT SUPER BOND-1 LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND CERAMIC BRACKETS Dent Zar, Inc. EBF Class II 1996-04-26
K960823 PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT Dentsply Intl. KLE Class II 1996-04-26
K961076 MM 324 Micro-Mega Societe Anonyme EFB Class I 1996-04-26
K960729 ENAMEL CONDITIONER (ENAMEL ETCHING AGENT) Dent Zar, Inc. EBF Class II 1996-04-26
K960595 FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETS Dent Zar, Inc. EBF Class II 1996-04-26
K960548 AH PLUS ROOT CANAL SEALER Dentsply Intl. KIF Class II 1996-04-26
K960599 SUPERIOR PHOTOCURING HYBRID COMPOSITE Dent Zar, Inc. EBF Class II 1996-04-26
K960598 CONCORD MARYLAND BRIDGE CEMENT Dent Zar, Inc. EBF Class II 1996-04-26
K960600 LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS Dent Zar, Inc. EBF Class II 1996-04-26
K960596 ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE Dent Zar, Inc. EBF Class II 1996-04-26
K960597 ORION-1 VL CROWN BASE AND POST CEMENT VISIBLE LIGHT CURE Dent Zar, Inc. EBF Class II 1996-04-26
K954976 POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION) Healex Products, Inc. EBG Class II 1996-04-25
K961211 ARGELITE 52+ Argen Precious Metals, Inc. EJT Class II 1996-04-25
K961190 GLY-ETCH Centrix, Inc. EBC Class II 1996-04-23
K961089 PULPDENT ENDOPREP II Pulpdent Corp. EKL Class I 1996-04-23
K961163 LARES RESEARCH AS-1 LOWSPEED HANDPIECE Lares Research, Inc. EFB Class I 1996-04-23
K960348 OSTEOGRAF/N-300 HYDROXYLAPATITE Ceramed Corp. LYC Class II 1996-04-22
K960353 OSTEOGRAF/LD-300 HYDROXYLAPATITE Ceramed Corp. LYC Class II 1996-04-18
K961285 ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION) Argen Precious Metals, Inc. EJT Class II 1996-04-18
K960938 PROV-KB Silicon-Und Composite Spezialitaten GmbH EBG Class II 1996-04-18
K960368 OSTEOGRAFT/N-700 HYDROXYLAPTITE Ceramed Corp. LYC Class II 1996-04-18
K954471 POWERS ANTI-BACTERIAL VALVE Powers Dental & Medical Technology, Inc. EIA Class I 1996-04-15
K960364 CU-200 LIGHT CURE UNIT Rolence Enterprise Co. , Ltd. EBZ Class II 1996-04-15
K960514 TMP MANDIBULAR COMPRESSION SYSTEM (MODIFICATION) Anspach Fixation Systems JEY Class II 1996-04-15
K960351 Q-LUX LIGHT CURE UNIT Rolence Enterprise Co. , Ltd. EBZ Class II 1996-04-15
K960292 GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS W. L. Gore & Associates, Inc. NPK Class II 1996-04-15
K960361 PERMAMESH-D HYDROXYLAPATITE MATRIX Ceramed Corp. LYC Class II 1996-04-15
K955176 DENTO-SURGE Ellman Intl., Inc. EKZ Class II 1996-04-15
K960164 BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140 Bio-Interfaces, Inc. LYC Class II 1996-04-10
K960245 VIP VICTOR INTERACTIVE PROBE Pro-Dentec EIX Class I 1996-04-04
K960914 3I OSSEOUS FIXATION SYSTEM(S) Implant Innovations, Inc. JEY Class II 1996-04-04
K954347 3I STANDARD THREADED IMPLANT Implant Innovations, Inc. DZE Class II 1996-04-01
K960819 HELIODENT DS Pelton & Crane Co. EAP Class II 1996-03-29
K955329 RESILIENCE M5 PROTECTION PLUS Confi-Dental Products Co. DYH Class II 1996-03-28
K960026 BIOHORIZONS DENTAL IMPLANT SYSTEM BioHorizons Implant Systems, Inc. DZE Class II 1996-03-28
K960719 STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE Dentalez Group EFA Class I 1996-03-28
K960507 STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES Dentalez Group EFA Class I 1996-03-28
K960541 LYNX DPA DISPOSABLE PROPHY ANGLE Mti Precision Products EFB Class I 1996-03-28
K960288 HA & TPS RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM Lifecore Biomedical, Inc. DZE Class II 1996-03-28
K960260 STAR TITAN SERIES MOTORS & ATTACHMENTS Dentalez Group EFA Class I 1996-03-28
K960365 ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000) Wallace A. Erickson & Co. KLE Class II 1996-03-28
K960910 INDERMIL DENTAL Loctite Corp. EMA Class II 1996-03-28
K955328 CONFI-BOND Confi-Dental Products Co. KLE Class II 1996-03-28
K960111 KIS MT4 The Implant Center of the Palm Beaches DZE Class II 1996-03-27
K960506 A-DEC PERFORMER CONTROL UNIT A-Dec, Inc. EIA Class I 1996-03-25
K960879 AMALGAMIBOND PLUS Parkell, Inc. KLE Class II 1996-03-22
K960565 ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE Dent Zar, Inc. EBF Class II 1996-03-22
K955838 ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR) Atrix Laboratories, Inc. NPK Class II 1996-03-21
K953865 SPACELINE FEEL 21 J. Morita USA, Inc. EFA Class I 1996-03-20
K955822 REMOVABLE HERBST APPLIANCE Univ. Dental Assoc. Department of Orthodontics LRK Class II 1996-03-20
K960110 KIS MT3 The Implant Center of the Palm Beaches DZE Class II 1996-03-20
K945847 FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE Friatec Medical Inc., USA DZE Class II 1996-03-15
K960112 KIS MT5 The Implant Center of the Palm Beaches DZE Class II 1996-03-15
K945849 FRIALIT(R)-2 STEPPED CYLINDER WITH FRIOS(R) TI-COATING Friatec Medical Inc., USA DZE Class II 1996-03-15
K955281 ENDOSSEOUS DENTAL IMPLANT & ACCESSORIES The Straumann Co. DZE Class II 1996-03-15
K960165 ALPHA-DENT COMPOSITE SURFACE SEALANT Wallace A. Erickson & Co. EBF Class II 1996-03-15
K960547 DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE Espe GmbH & Co. Kg. ELW Class II 1996-03-15
K960480 IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013 Vident ELL Class II 1996-03-15
K960270 DENTALOGIC Protecs Syringes International Corp. EJI Class II 1996-03-15
K945848 FRIALIT(R)-2 DENTAL IMPLANT Friatec Medical Inc., USA DZE Class II 1996-03-15
K955932 EXAFLEX IMPRESSION MATERIAL (MODIFICATION) GC America, Inc. ELW Class II 1996-03-11
K954385 SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM Synthes (Usa) JEY Class II 1996-03-08
K955619 5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS Calcitek, Inc. DZE Class II 1996-03-08
K953806 SYNTHES (USA) MIDFACIAL SYSTEM Synthes (Usa) JEY Class II 1996-03-08
K954867 IONOSIT SEAL Foremost Dental Mfg., Inc. EBC Class II 1996-03-08
K954988 CRYSTALLESSENCE Confi-Dental Products Co. EBF Class II 1996-03-08
K960371 INTERPORE THREADED IMPLANT Interpore Intl. DZE Class II 1996-03-08
K955050 JETSTREAM CAVITY PREPARATION SYSTEM Dove Systems, Inc. KOJ Class II 1996-03-07
K955892 HYDROCOLLOID TRAY MATERIALS, MED. TO HIGH VISCOSITY/WASH MATERIALS, LOW VISCOSITY Van R Dental Products, Inc. ELW Class II 1996-03-05
K943403 CONDOR ULTRASONIC INSERTS Condor Products, Inc. ELC Class II 1996-03-05

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