meddevicedb.com FDA Device Reference

Review Panel

Dental FDA 510(k) Clearances & Devices

Cleared Devices
12,679
Product Codes (page)
31
Latest Decision
1995-06-22

Clearances · page 84 of 127

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K952121 3M RESIN CEMENT 3M Medical Products Group EMA Class II 1995-06-22
K952403 AUROLITE 80 Argen Precious Metals, Inc. EJT Class II 1995-06-21
K952123 MS EMULSION Parkell, Inc. KLE Class II 1995-06-20
K952124 ABOND Parkell, Inc. KLE Class II 1995-06-20
K952448 3.3MM ACCESSORIES Nobelpharma USA, Inc. DZE Class II 1995-06-20
K952499 VS1 PLUS Metalor Dental USA Corp. EJT Class II 1995-06-16
K952402 AURIUM 68M Argen Precious Metals, Inc. EJT Class II 1995-06-16
K945820 DESRA D.S.R.A., Inc. LQZ Class II 1995-06-15
K951789 PALLIAG NF IV Degussa Corp. EJT Class II 1995-06-14
K946112 ELASTOMERIC SLEEP APPLIANCE Village Park Orthodontics LQZ Class II 1995-06-14
K941393 ITI ANGLED ABUTMENT The Straumann Co. DZE Class II 1995-06-14
K946198 IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTOR Sterngold DZE Class II 1995-06-14
K951786 DEGULOR A Degussa Corp. EJT Class II 1995-06-12
K951791 DEPALOR Degussa Corp. EJT Class II 1995-06-12
K951790 PONTALLOR 3 Degussa Corp. EJT Class II 1995-06-12
K951788 DEGULOR S Degussa Corp. EJT Class II 1995-06-12
K950237 DIGITEST Parkell, Inc. EAT Class II 1995-06-09
K951787 DEGUBOND 4 Degussa Corp. EJT Class II 1995-06-08
K944709 W&H 896 TOP LIGH HIGHSPEED A-Dec, Inc. EFB Class I 1995-06-08
K951065 SURGICAL INSTRUMENT MOTOTRS AND ACCESSORIES/ATTACHMENTS Steri-Oss, Inc. DZE Class II 1995-06-08
K951663 TYTIN R Kerr Corporation (Danbury) EJJ Class II 1995-06-06
K951784 PRIMALLOR 1 Degussa Corp. EJT Class II 1995-06-06
K951785 PRIMALLOR 2 Degussa Corp. EJT Class II 1995-06-06
K950239 SENSIMATIC 500SE Parkell, Inc. EKZ Class II 1995-06-06
K952122 V-GNATHOS PLUS Metalor Dental USA Corp. EJT Class II 1995-06-06
K951937 BIOPATH SELF-TAPPING DENTAL IMPLANT SYSTEM (5MM, 6MM) Bio Path DZE Class II 1995-06-05
K951779 DEGULOR M Degussa Corp. EJT Class II 1995-06-02
K952193 OSTEOTOMES Steri-Oss, Inc. DZE Class II 1995-06-02
K944708 W&H 895 TOP LIGH HIGHSPEED FIBEROPTIC SINGLE SPRAY A-Dec, Inc. EFB Class I 1995-06-02
K951781 PORS ON PLUS Degussa Corp. EJT Class II 1995-06-02
K944716 W&H 796 TOP AIR TURBINE MINI-HEAD A-Dec, Inc. EFB Class I 1995-06-02
K944717 W&H 798 TOP AIR TURBINE TRIPLE SPRAY A-Dec, Inc. EFB Class I 1995-06-02
K951783 BOND-ON 4 Degussa Corp. EJT Class II 1995-06-02
K950993 BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH John O. Butler EFW Class I 1995-06-02
K944715 W&H 795 TOP AIR TURBINE SINGLE SPRAY A-Dec, Inc. EFB Class I 1995-06-02
K944710 W&H 898 TOP LIGHT HIGHSPEED A-Dec, Inc. EFB Class I 1995-06-02
K945674 MANDIBULAR BONE DISTRACTOR Howmedica Corp. MQN Class II 1995-06-02
K951782 STABILOR G Degussa Corp. EJT Class II 1995-06-01
K951780 STABILOR NF IV Degussa Corp. EJT Class II 1995-06-01
K951465 SUNLITE 1275 Fen Dental Mfg., Inc. EBZ Class II 1995-05-31
K951777 DEGUSTAR GA-2 Degussa Corp. EJT Class II 1995-05-31
K951270 PULPDENT GLASS IONOMER CEMENTS Pulpdent Corp. EMA Class II 1995-05-31
K923310 OSTEOGEN (HA RESORB) Impladent LYC Class II 1995-05-31
K951778 DEGUDENT U Degussa Corp. EJT Class II 1995-05-31
K951836 COMPOLGLASS COMPOGLASS SCA Ivoclar North America, Inc. EBF Class II 1995-05-25
K951865 ULTRA SPHERICAL AMALGAM ALLOY Goldsmith & Revere, Inc. EJJ Class II 1995-05-25
K950763 LOWE KLEARWAY Dr. Alan A. Lowe, Inc. LRK Class II 1995-05-25
K941066 DENTAL 911 L.A.F. Industries, Inc. EMB Class I 1995-05-24
K945698 COLTOLUX 3, COLTOLUX 4 Coltene/Whaledent, Inc. EBZ Class II 1995-05-24
K943419 ORTHODONTIC ELASTOMERIC LAGATURE MODULE Jon-Ko Products, Inc. ECI Class I 1995-05-24
K950106 COLTOLUX LIGHT METER Coltene/Whaledent, Inc. EBZ Class II 1995-05-24
K943418 ORTHODONTIC ELASTOMERIC SEPARATOR MODULE Jon-Ko Products, Inc. ECI Class I 1995-05-23
K951776 BAND SEATER Ormco Corp. ECR Class I 1995-05-23
K951867 PERMAQUIK BONDING PRIMER Ultradent Products, Inc. KLE Class II 1995-05-23
K943421 ORTHODONITC ELASTOMERIC SLEEVING Jon-Ko Products, Inc. DZD Class I 1995-05-23
K951238 SAFE-TIPS EZ Safe Wave Products, Inc. EIA Class I 1995-05-23
K951864 PRIME & BOND DIRECT COMPOSITE BONDING AGENT Dentsply Intl. KLE Class II 1995-05-23
K950299 CEREC 2 Pelton & Crane Co. ELW Class II 1995-05-23
K943417 ORTHODONTIC ELASTOMERIC TUBE/THREAD Jon-Ko Products, Inc. ECI Class I 1995-05-23
K943420 ORTHODONTIC ELASTOMERIC CHAIN Jon-Ko Products, Inc. ECI Class I 1995-05-23
K951555 FUJI IX GC America, Inc. EMA Class II 1995-05-23
K944327 INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM Calcitek, Inc. DZE Class II 1995-05-16
K951427 AMERICAN DENTAL PRODUCTS (ADP), COMPOSITE RESTORATIVE MATERIAL American Dental Products, Inc. EBF Class II 1995-05-15
K951272 RELACS 7000 Micro-Mega Societe Anonyme ELC Class II 1995-05-12
K951220 HEMA-GLU Health-Dent Intl., Inc. KLE Class II 1995-05-12
K951583 PERMAQUIK BONDING PRIMER Ultradent Products, Inc. KLE Class II 1995-05-12
K951426 AMERICAN DENTAL PRODUCTS (ADP), VISIBLE LIGHT CURE COMPOSITE DENTAL RESTORATIVE MATERIAL American Dental Products, Inc. EBF Class II 1995-05-12
K951917 JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS Johnson & Johnson Consumer Products, Inc. JES Class I 1995-05-10
K951582 ULTRADENT PORCELAIN ETCH Ultradent Products, Inc. EIH Class II 1995-05-10
K951019 INTRAORAL VIDEO SCOPE AND WINDOW TUBE Cuda Products Co. EIA Class I 1995-05-10
K950567 BIO-APATITE 6140 HA PARTICLES Bio-Interfaces, Inc. LYC Class II 1995-05-09
K950238 GENTAL PULSE Parkell, Inc. EAT Class II 1995-05-09
K941608 INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING Calcitek, Inc. DZE Class II 1995-05-05
K951425 SPECTRUM CURING LIGHT POLYMERIZATION UNIT Dentsply Intl. EBZ Class II 1995-05-05
K951392 MINIBONEPLATE SYSTEM Ace Surgical Supply Co., Inc. JEY Class II 1995-05-05
K950893 KIS-V PRE-ANGULATED AND WIDE BODY ABUTMENTS The Implant Center of the Palm Beaches DZE Class II 1995-05-05
K950992 CERAMAFLEX BRACKET SYSTEM Tp Orthodontics, Inc. NJM Class II 1995-05-03
K951296 DELTON F PIT & FISSURE SEALANT Dentsply Intl. EBC Class II 1995-05-03
K950446 BONE CUTTING INSTRUMENT AND ACCESSORIES Steri-Oss, Inc. DZE Class II 1995-05-03
K951183 IN-CERAM SPINELL Vident EIH Class II 1995-05-02
K912521 DENTAL IMPLANT SYSTEM 4.0MM AND 5.5MM LENGTH Bud Industries, Inc. DZE Class II 1995-05-02
K951511 TYTIN ADMIX Kerr Corporation (Danbury) EJJ Class II 1995-05-02
K951016 DISPOSABLE PROPHYLAXIS ANGLE Preventive Technologies, Inc. EHK Class I 1995-05-02
K930868 DYNA IMPLANT DESIGN Dyna Dental Engineering BV DZE Class II 1995-04-28
K951380 VILA PC Health-Dent Intl., Inc. DYH Class II 1995-04-27
K943157 ORAL-B ULTRAFLOSS WITH FLLUORIDE Oral-B Laboratories JES Class I 1995-04-27
K942633 ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE Oral-B Laboratories JET Class I 1995-04-27
K942690 RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE Ranir/Dcp Corp. JES Class I 1995-04-27
K951381 VILA Health-Dent Intl., Inc. DYH Class II 1995-04-27
K944886 COLGATE PRECISION MINT WZXED DENTAL FLOSS Colgate-Palmolive Co. JES Class I 1995-04-27
K942689 RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE Ranir/Dcp Corp. JES Class I 1995-04-27
K950511 BLL-FIL 6140 PARTICLES Bio-Interfaces, Inc. LYC Class II 1995-04-27
K944725 KIS-II STR FIXTURES Implant Center of the Palm Beaches DZE Class II 1995-04-26
K950936 BONE CUTTING INSTRUMENT AND ACCESSORIES Steri-Oss, Inc. DZE Class II 1995-04-20
K951235 GIROC Health-Dent Intl., Inc. DYH Class II 1995-04-20
K950532 TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY Trophy Radiologie EAP Class II 1995-04-19
K951236 PRO-LOCK Health-Dent Intl., Inc. DYH Class II 1995-04-18
K951297 HARMONY LINE KF Ivoclar North America, Inc. EJT Class II 1995-04-18
K951298 MAXIGOLD KF Ivoclar North America, Inc. EJT Class II 1995-04-18
K950175 THE AQUA-AIR PROFESSIONAL FIELD UNIT(S) Aqua-Air Medical Devices, Inc. EIA Class I 1995-04-18

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