meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
35
Latest Decision
1996-03-05

Clearances · page 81 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K955655 MIDWEST ONE Midwest Dental Products Corp. EFB Class I 1996-03-05
K931647 PHOENIX 4.0 MM HA COATED DENTAL IMPLANT Vancouver Implant Center DZE Class II 1996-03-05
K960028 ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM Dentsply Intl. EAP Class II 1996-03-01
K960403 DIAMOND (CODE NAME PT-054) J.F. Jelenko & Co., Inc. EJT Class II 1996-02-26
K960464 C & B METABOND (MODIFICATION) Parkell, Inc. EMA Class II 1996-02-26
K954512 RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM Lifecore Biomedical, Inc. DZE Class II 1996-02-23
K960352 ALLRAP/SLIP-N-GRIP Dental Disposables Intl., Inc. EFB Class I 1996-02-21
K960399 TOPAZ J.F. Jelenko & Co., Inc. EJT Class II 1996-02-21
K960122 ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL Wallace A. Erickson & Co. EBG Class II 1996-02-21
K960256 DEGUDENT LS Degussa Corp. EJT Class II 1996-02-21
K953898 ACL-5500 PRECISION CURING UNIT (PCU) Ion Laser Technology EBZ Class II 1996-02-15
K955640 LORENZ MANDIBULAR DISTRACTOR Biomet, Inc. MQN Class II 1996-02-14
K960226 DG 88 Degussa Corp. EJT Class II 1996-02-14
K955528 CLP BONNET Clp Products DZB Class II 1996-02-14
K960063 BOSWORTH IMPRESSION MATERIAL I Harry J. Bosworth Co. ELW Class II 1996-02-14
K955427 3I TITANIUM PLASMA SPRAYED STANDARD THREADED & SELF-TAPPING IMPLANTS Implant Innovations, Inc. DZE Class II 1996-02-09
K943604 INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM Calcitek, Inc. DZE Class II 1996-02-08
K955445 CARIES FINDER Danville Engineering, Inc. LFC Class II 1996-02-08
K955428 3I HYDROXYLAPATITE COATED STANDARD THREADED & SELF-TAPPING IMPLANTS Implant Innovations, Inc. DZE Class II 1996-02-08
K955503 ADJUSTABLE PM POSITIONER Jonathan A. Parker, D.D.S. LQZ Class II 1996-02-08
K955654 SHORTSTOP DISPOSABLE PROPHY ANGLE Spintech, Inc. EFB Class I 1996-02-08
K960021 CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMS Calcitek, Inc. DZE Class II 1996-02-08
K955740 GLUFLORMA Midwest Orthodontic Mfg. KLE Class II 1996-02-08
K960104 BIOCCLUS 4 Degussa Corp. EJT Class II 1996-02-06
K952847 NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR Ace Surgical Supply Co., Inc. MQN Class II 1996-02-06
K950306 IMTEC BIOBARRIER Imtec Corp. LYC Class II 1996-02-06
K955697 ABUTMENT RETRIEVAL KIT Nobelpharma USA, Inc. DZE Class II 1996-01-30
K955492 INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT Interpore Intl. DZE Class II 1996-01-30
K945256 MTC 7707 HIGH SPEED AIR TURBINE Mtc Industries and Research, Ltd. EFB Class I 1996-01-29
K954990 DENTAL DAM The Hygenic Corp. EIE Class I 1996-01-26
K955285 GALLOY Southern Dental Industries, Inc. EJJ Class II 1996-01-24
K955521 ALPHA-DENT COPAL CAVITY VARNISH Wallace A. Erickson & Co. LBH Class II 1996-01-24
K955369 MEMFIX The Straumann Co. DZL Class II 1996-01-23
K955337 OPAKER Kerr Dental Materials Center EBF Class II 1996-01-23
K955096 CAPSET CALCIUM SULFATE BONE GRAFT PLASTER Lifecore Biomedical, Inc. LYC Class II 1996-01-23
K955372 BALL ATTACHMENT SYSTEM Nobelpharma USA, Inc. DZE Class II 1996-01-23
K954820 SCALEX 800 Dentamerica ELC Class II 1996-01-18
K953589 TOKUYAMA SOFT RELINING Tokuyama America, Inc. EBI Class II 1996-01-18
K954722 MICRO-DISPENSER 7000 & MICRODISPENSER 8000 NOUVAG AG EFB Class I 1996-01-16
K954790 PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS Tulsa Dental Products, Ltd. DZA Class I 1996-01-16
K955048 KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM The Implant Center of the Palm Beaches DZE Class II 1996-01-11
K954865 RESTORE HA DENTAL IMPLANT SYSTEM Lifecore Biomedical, Inc. DZE Class II 1996-01-11
K954819 RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEM Lifecore Biomedical, Inc. DZE Class II 1996-01-11
K955140 2.0 X 6MM SCREW Brasseler USA I, L.P. DZL Class II 1996-01-05
K953707 MEDTROL DENTAL KIT Medtrol, Inc. EKJ Class I 1996-01-04
K954827 SEALITE FL Sybron Dental Specialties, Inc. EBC Class II 1996-01-04
K955763 OPTILUX 400 Demetron Research Corp. EBZ Class II 1996-01-04
K955333 SPIRIT MB Ormco Corp. DYW Class II 1996-01-04
K954763 BIO-INTERFACES, INC,. BII-PLAST Bio-Interfaces, Inc. LYC Class II 1996-01-04
K954991 PHASE CHANGE DENTAL LUBRICANT Phase Change EFB Class I 1996-01-04
K933646 CAL-FORM DENTAL IMPLANTS Cal-Form, Inc. DZE Class II 1996-01-04
K955336 SNOREFREE Scott Feldman Dds & Norman Shapiro Dds LRK Class II 1996-01-04
K955331 BELLEGLASHP Sybron Dental Specialties, Inc. EBG Class II 1996-01-02
K955759 LITEX 680 Dentamerica EBZ Class II 1996-01-02
K954631 OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE Ceramed Corp. LYC Class II 1996-01-02
K953936 ATLANTIS Trophy Radiologie EAP Class II 1995-12-28
K950555 J SINGLE USE HEAD AND JD REUSABLE HANDLE Micro-Mega Societe Anonyme EGS Class I 1995-12-28
K955406 SCAN WHITE 12 ML Vident ELW Class II 1995-12-28
K955530 RANIR HI-TECHNOLOGY DENTAL FLOSS Ranir/Dcp Corp. EFW Class I 1995-12-28
K955279 D-SENSE Centrix, Inc. KLE Class II 1995-12-28
K955509 MIDAS GOLD ELECTROFORMING SYSTEM Austenal, Inc. EJT Class II 1995-12-28
K955465 DEGUPRINT Degussa Corp. ELW Class II 1995-12-28
K954637 AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER American Dental Products, Inc. EBI Class II 1995-12-28
K955069 PLAYSKOOL Hasbro, Inc. KKO Class II 1995-12-22
K953101 PARAGON IMPLANT SYSTEM Core-Vent Bio-Engineering, Inc. DZE Class II 1995-12-21
K952922 BIOGRAN BIOACTIVE GLASS SYNTHETIC BONE GRAFT MATERIAL Orthovita Co. LYC Class II 1995-12-19
K953558 KIS II LG HEX SCREW & CYLINDER IMPLANTS The Implant Center of the Palm Beaches DZE Class II 1995-12-19
K955292 AELITEFLO Bisco, Inc. EBF Class II 1995-12-13
K955089 ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT Wallace A. Erickson & Co. EMA Class II 1995-12-13
K955118 DEGUBOND X-LITE PLUS Degussa Corp. EJT Class II 1995-12-11
K955429 PROSTYLE INTRA Planmeca Oy EHD Class II 1995-12-11
K955946 ACETAL DENTAL/PREFORMED CLASP Pressing DI Monticelli Rag. Stefano EHP Class I 1995-12-11
K954971 ACETAL DENTAL/PREFORMED CLASP B & H Technical Services , Ltd. EHP Class I 1995-12-11
K955068 OPTIBOND 2A PRECOAT Sybron Dental Specialties, Inc. EMA Class II 1995-12-11
K955070 OPTIBOND; OPTIAID, OPTIREP, OPTISHINE, OPTICHROMA, OPTIFARB & OPTIWAK Optimal Dental (Usa) EIH Class II 1995-12-11
K955017 PULPDENT RESILUTE Pulpdent Corp. EMA Class II 1995-12-01
K955027 DEGUBOND X-LITE Degussa Corp. EJT Class II 1995-12-01
K955242 TITANIUM BIRD BEAK PLIER Sybron Dental Specialties, Inc. JEX Class I 1995-12-01
K954192 IMPREGUM PENTA Espe GmbH & Co. Kg. ELW Class II 1995-12-01
K954810 MYERSON IR DENTURE BASE Austenal, Inc. EBI Class II 1995-11-29
K954929 CHARISMA SINGLE DOSE Heraeus Kulzer, Inc. EBF Class II 1995-11-27
K952167 IMZ BONE TACK SYSTEM Interpore Intl. DZL Class II 1995-11-21
K954180 MICROGLISS Espe GmbH & Co. Kg. ELW Class II 1995-11-21
K953912 JACOBYSCOPE Perioview, Inc. EIA Class I 1995-11-15
K954662 THERMALASTIC/TRIPOLYVINALENE Tak Systems ELW Class II 1995-11-15
K954837 DW260 19 Ivoclar North America, Inc. EJT Class II 1995-11-15
K954876 AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA American Dental Products, Inc. EMA Class II 1995-11-15
K946345 INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEM Calcitek, Inc. DZE Class II 1995-11-15
K946319 INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM Calcitek, Inc. DZE Class II 1995-11-15
K954012 DISPOSABLE PROPHY HANDPIECE Denticator Intl., Inc. EFB Class I 1995-11-08
K953234 SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-B3 The Implant Center of the Palm Beaches DZE Class II 1995-11-08
K954068 GENERAL HYGIENE KIT Physician Industries, Inc. KHR Class I 1995-11-08
K954802 RITE-ANGLE DISPOSABLE PROPHY ANGLES Ash-USA EGS Class I 1995-11-08
K954762 NEXUS Sybron Dental Specialties, Inc. EMA Class II 1995-11-02
K954761 FINESSE LOW-FUSING PORCELAIN SYSTEM Dentsply Intl. EIH Class II 1995-11-02
K952985 WIDE SCREWS TP-5B. PROS G5, TOOLS G5 OR 17-4 SS Implant Center of the Palm Beaches DZE Class II 1995-10-31
K952998 TP SCREW IMPLANT 3.75, 4.0-B5 Implant Center of the Palm Beaches DZE Class II 1995-10-31
K952997 PRE ANGULATED PROSTH: 15 DEG ANGLED, 25,& 25 CONE ANGLED Implant Center of the Palm Beaches DZE Class II 1995-10-31
K953001 TP-4K SCREW IMPLANT 3.3, 3.75, 4.0 Implant Center of the Palm Beaches DZE Class II 1995-10-31
K952994 TP-4 WIDE CYLINDER IMPLANTS Implant Center of the Palm Beaches DZE Class II 1995-10-31

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