Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 50
- Latest Decision
- 1987-07-02
Clearances · page 110 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K864540 | PLAK VAK - PV-10 | Paul S. Barclay, D.D.S. , Ltd. | EFS | Class I | 1987-07-02 |
| K872225 | SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER | Block Drug Company, Inc. | KOT | Class I | 1987-06-30 |
| K871493 | DENTI-TRAY(TM) | Advanced Medical, Inc. | EKW | Class I | 1987-06-24 |
| K872171 | PERIOTEST | Siemens Medical Solutions USA, Inc. | EKX | Class I | 1987-06-23 |
| K871160 | TRUETECH MEDICAL, INC. DENTURE CUPS | Zenex Medical, Inc. | ELM | Class II | 1987-06-23 |
| K872210 | IMPRESSION TRAY | Dentsply Intl. | EBH | Class I | 1987-06-22 |
| K871497 | LINER OR GSRI-PNF | Gulf South Research Institute | EBI | Class II | 1987-06-17 |
| K870414 | QUIK-BRUSH | Intl. Medication Systems, Ltd. | EFW | Class I | 1987-06-11 |
| K871409 | VINYL POLYSILOXANE IMPRESSION SYSTEM | Crown Delta Corp. | ELW | Class II | 1987-06-11 |
| K870280 | ACCUDENT ACCUPROBE | Accudent, Inc. | EIX | Class I | 1987-06-08 |
| K871439 | COSMETIC SINGLE SPAN BRIDGE | Cosmetic Dental Technologies, Inc. | EGG | Class I | 1987-06-08 |
| K871648 | TMJ CANNULA SET | Aspen Laboratories, Inc. | DZI | Class II | 1987-06-08 |
| K871808 | DUCERAM-METAL-CERAMIC DENTAL PORCELAIN SYSTEM | Degussa Dental, Inc. | ELL | Class II | 1987-06-05 |
| K871980 | D-23 DENTURE ADHESIVE | Solar Dental Co., Inc. | KOJ | Class II | 1987-06-05 |
| K871937 | IMPRESSION SYRINGE | Dentsply Intl. | EID | Class I | 1987-06-05 |
| K871219 | TITANODONT SUBCORTICAL IMPLANT WITH POROCOAT | Depuy, Inc. | DZE | Class II | 1987-06-04 |
| K871359 | CHECK-MATE AND CHECK-MATE [+] | Veritech, Inc. | EFW | Class I | 1987-05-29 |
| K871295 | ADAPTALITE* PORCELAIN VENEER CEMENTATION SYSTEM | Johnson & Johnson Professionals, Inc. | EBF | Class II | 1987-05-29 |
| K871270 | PERFORM DENTURE BASE RESIN | Ipco Corp. | EBF | Class II | 1987-05-29 |
| K871736 | CARERITE BIOPACK GINGIVAL RETRACTION CORD | Cost Rite Health Products, Inc. | JES | Class I | 1987-05-27 |
| K871784 | TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI | Colgate-Hoyt Laboratories | KMT | Class I | 1987-05-27 |
| K870765 | CANNULATED INSTRUMENT CLEANERS | Treace Medical, Inc. | EKW | Class I | 1987-05-27 |
| K871909 | COMPOSITE RESTORATIVE CARRIER | Dentsply Intl. | EIY | Class I | 1987-05-27 |
| K871562 | IONOCAL | Foremost Dental Mfg., Inc. | EMA | Class II | 1987-05-20 |
| K870230 | ALLOY FOR DENTAL AMALGAM LUXALLOY NON GAMMA 2 | Degussa Dental, Inc. | EJJ | Class II | 1987-05-20 |
| K871038 | LUTEMOLL (BIOPLAST) | B. L. Dental Co. | EBI | Class II | 1987-05-19 |
| K871591 | ORMCO GEL-ETCH | Scientific Pharmaceuticals, Inc. | DYH | Class II | 1987-05-18 |
| K871639 | DENTAL DIAMOND BURS | E&D Dental Manufacturing Co. | DZP | Class I | 1987-05-18 |
| K870677 | NEY-ORO 41 | Deringer-Ney, Inc. | EJT | Class II | 1987-05-12 |
| K871504 | DISPOSABLE PERIODONTAL PROBE | Periodontal Health Brush, Inc. | EIX | Class I | 1987-05-06 |
| K871051 | FIAD EXPLOR-X; MODEL 70 KVP | United States Dental | EHD | Class II | 1987-05-04 |
| K864226 | JOHNSON & JOHNSON STAINING REMOVING COMPOUND | Johnson & Johnson Professionals, Inc. | EJR | Class I | 1987-05-01 |
| K870797 | PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE | Safco Dental Supply | EKX | Class I | 1987-05-01 |
| K871464 | MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STER | Medgroup Enterprises, Inc. | EFN | Class I | 1987-04-30 |
| K870383 | ALGINATE WOOL FIBER | Adri | KHR | Class I | 1987-04-30 |
| K870590 | CURETTE, PERIODONTAL, COLUMBIA UNIVERSITY | Military Engineering, Inc. | EMS | Class I | 1987-04-16 |
| K871315 | ORAL ASPIRATOR | Endovations | DYN | Class I | 1987-04-15 |
| K871392 | DR FLOSSER REFILL | Flossrite Corp. | JES | Class I | 1987-04-15 |
| K871312 | FIBREFLEX | Biomedical Composites, Ltd. | EBI | Class II | 1987-04-15 |
| K871393 | DR FLOSSER, FLOSSING AID/FLOSS HOLDING DEVICE | Flossrite Corp. | JES | Class I | 1987-04-15 |
| K864732 | GRADTECH SYRINGE SYSTEM | Gradtech | EGM | Class II | 1987-04-15 |
| K871288 | GDC 1830 CASTING ALLOY | Deringer-Ney, Inc. | EJS | Class II | 1987-04-15 |
| K870118 | MODEL 6110B DENTAPHOR | Life-Tech Intl., Inc. | EAT | Class II | 1987-04-10 |
| K864720 | LIGHT-CURED PERIODONTAL DRESSING | Dentsply Intl. | EMA | Class II | 1987-04-07 |
| K864376 | FIBERBOND | Dentec, Inc. | DYT | Class I | 1987-04-07 |
| K870921 | DENTAL NEEDLE (CARTRIDGE TYPE) | Churchill Corp. | DZM | Class I | 1987-04-03 |
| K870589 | ELEVATOR, ROOT, SINGLE-ENDED | Military Engineering, Inc. | EMJ | Class I | 1987-04-03 |
| K871165 | LUMIFOR(TM) COMPOSITE | Columbus Dental Mfg. Co. | EBF | Class II | 1987-04-03 |
| K870906 | CARERITE INTERDENTAL BRUSHES, MODELS 3500 & 4500 | Cost Rite Health Products, Inc. | EFW | Class I | 1987-03-30 |
| K870599 | TIP, DENTAL SUCTION APPARATUS | Military Engineering, Inc. | DYN | Class I | 1987-03-23 |
| K870908 | STEADY RESIN | Great Lakes Orthodontics, Ltd. | EBI | Class II | 1987-03-19 |
| K870011 | CONTRASYL IMPRESSION MATERIAL | Contracap | ELW | Class II | 1987-03-19 |
| K870996 | SEWON DENTAL FLOSSER | Sewon Industry | JES | Class I | 1987-03-19 |
| K870875 | COAT-A-COUNT PCP KIT NUMBER TKPC1 | Diagnostic Products Corp. | LCN | Class I | 1987-03-19 |
| K870211 | BONDEX* GLASS IONOMER CEMENT | Johnson & Johnson Professionals, Inc. | EMA | Class II | 1987-03-18 |
| K864455 | THE EXPERIMENTAL | Martin H. Kaufmann | EFW | Class I | 1987-03-18 |
| K870024 | PONTALLOR 4 DENTAL ALLOY | Degussa Dental, Inc. | EJT | Class II | 1987-03-11 |
| K863630 | AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL | Austenal Dental, Inc. | EBI | Class II | 1987-03-11 |
| K864970 | TERUMO DENTAL NEEDLES | Terumo Medical Corp. | DZM | Class I | 1987-03-10 |
| K870628 | MICROBOND COMPOSITE KIT FOR CERAMIC BONDING SYSTEM | Chem-E-Dent | EBF | Class II | 1987-03-06 |
| K870501 | THE EQUALIZER AIRWAY DEVICE | Sleep Renewal, Inc. | LQZ | Class II | 1987-03-04 |
| K865049 | GDC 1824 | Deringer-Ney, Inc. | EJT | Class II | 1987-03-04 |
| K870579 | ALPHA-DENT PIT AND FISSURE SEALANT | Wallace A. Erickson & Co. | EBC | Class II | 1987-03-02 |
| K870331 | IMZ INTRAMOBILE CYLINDER IMPLANT SYSTEM COMPONENTS | Interpore Intl. | EGG | Class I | 1987-03-02 |
| K870266 | COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM | Coltene, Inc. | EBF | Class II | 1987-02-27 |
| K864976 | SOLUSET CALCIUM DEMINERALIZING SOLUTION | Endo Technic Corp. | EKS | Class I | 1987-02-27 |
| K864708 | SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN | Ivoclar USA, Inc. | EBI | Class II | 1987-02-25 |
| K864995 | OSSEOINTEGRATED FIXTURES FOR USE IN DENTAL IMPLANT | Vent-Plant Corporation, Inc. | DZE | Class II | 1987-02-25 |
| K870243 | BURNETT TMJ APPLIANCE | Medrad, Inc. | EAG | Class II | 1987-02-24 |
| K870130 | DEN-MAT SECURE ANTI-ROTATIONAL POST-CORE SYSTEM | Den-Mat Corp. | ELR | Class I | 1987-02-19 |
| K865028 | ESPE CHELON-SILVER | Espe GmbH (Us) | EBF | Class II | 1987-02-19 |
| K870334 | BOSTON POST CEMENT | Scientific Pharmaceuticals, Inc. | EMA | Class II | 1987-02-19 |
| K864996 | ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30 | Dentsply Intl. | ELC | Class II | 1987-02-19 |
| K862557 | AUSTENAL ACUSOFT SOFT LINER | Austenal Dental, Inc. | EBI | Class II | 1987-02-19 |
| K870536 | GEM ORTHODONTIC BRACKET | Ormco Corp. | EJF | Class I | 1987-02-19 |
| K870177 | ENDOBRUSH | C & S Microinstruments , Ltd. | EKS | Class I | 1987-02-19 |
| K870148 | DURA ORTHO ACRYLIC | Reliance Dental Mfg. Co. | EBI | Class II | 1987-02-19 |
| K865025 | AUSTENAL CONDENSING INSTRUMENT | Austenal Dental, Inc. | EKG | Class I | 1987-02-19 |
| K870209 | NEXADENT (DENTAL CEMENT) | Bionexus, Inc. | EMA | Class II | 1987-02-19 |
| K864922 | DENTAL HANDPIECES AND ATTACHMENT | E&D Dental Manufacturing Co. | EKS | Class I | 1987-02-19 |
| K864724 | MODI. OF DENTAL CERAMIC FOR FABRICATION OF CROWN | Dentsply Intl. | ELL | Class II | 1987-02-17 |
| K864621 | VAC - RITE RIGHT ANGLE ASPIRATOR TUBE & HOLDER | Seldoren , Ltd. | EHZ | Class I | 1987-02-13 |
| K864861 | INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM | Instrumentations Unltd. | EGM | Class II | 1987-02-13 |
| K870236 | PANORAMIC X-RAY MODEL PC-1000 | Panoramic Corp. | EHD | Class II | 1987-02-13 |
| K865082 | PROPHY CARE SOLUTION | Imd, Inc. | EJR | Class I | 1987-02-12 |
| K864572 | FIXTECTOR | Prodent Intl., Inc. | EFH | Class I | 1987-02-12 |
| K864775 | CHISEL (OSTEOTOME, GOUGE, ETC.) | New England Surgical Instrument Corp. | EMM | Class I | 1987-02-12 |
| K864898 | FOREMOST DENTIN ADHESIVE | Foremost Dental Mfg., Inc. | EMA | Class II | 1987-02-12 |
| K864709 | IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL | Ivoclar USA, Inc. | EBI | Class II | 1987-02-10 |
| K864832 | DENTAL FLOSS | Westone Products , Ltd. | JES | Class I | 1987-02-10 |
| K864734 | HALL ORAL IMPLANT SYSTEM | Hall Surgical, Division of Zimmer, Inc. | DZE | Class II | 1987-02-10 |
| K864707 | SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH | Ivoclar USA, Inc. | ELM | Class II | 1987-02-10 |
| K864826 | A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY) | Austenal Dental, Inc. | EJH | Class II | 1987-02-10 |
| K864757 | MODIFIED VINYLAC PRESS PACK DENTURE RESIN | Astron Dental Corp. | EBI | Class II | 1987-02-10 |
| K862854 | OSTEO TITANIUM DENTAL IMPLANT | Osteo Implant Corp. | DZE | Class II | 1987-02-10 |
| K864710 | ISOSIT N | Ivoclar USA, Inc. | EBF | Class II | 1987-02-10 |
| K870032 | REVISED T-SCAN SYSTEM | Sentek, Inc. | EFH | Class I | 1987-02-02 |
| K870047 | COLTENE RAPID | Coltene, Inc. | ELW | Class II | 1987-01-29 |
| K864725 | MODI. DICOR CASTABLE CERAMIC/ALL PORCELAIN BRIDGES | Dentsply Intl. | EMA | Class II | 1987-01-21 |
| K863709 | CHALLENGE ORTHODONTIC BONDING ADHESIVE | Ormco Corp. | DYH | Class II | 1987-01-21 |
12,679 clearances in the Dental panel. Data: openFDA.