Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 44
- Latest Decision
- 1989-01-10
Clearances · page 107 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K884356 | NORITAKE SUPER PORCELAIN EX-3 | Noritake Co., Inc. | EIH | Class II | 1989-01-10 |
| K885086 | TIN COATED NITI ORTHODONTIC ARCH WIRES | Flexmedics | EJF | Class I | 1989-01-10 |
| K884813 | MODEL 200A ELECTRONIC FORCE-SENSING PROBE | Vine Valley Research | EIL | Class I | 1989-01-05 |
| K884381 | PALGAFLEX AND PALGAFLEX-QUICK | Espe GmbH (Us) | ELW | Class II | 1989-01-04 |
| K884245 | PERFECT CHOICE | Challenge Products, Inc. | EJK | Class II | 1989-01-04 |
| K885056 | TWIXEL(TM) | Fouts Development, Inc. | JES | Class I | 1989-01-04 |
| K884681 | UNIREST LC PAINT-ON RESTORATIVE & VENEER CEMENT | Scientific Pharmaceuticals, Inc. | EBF | Class II | 1989-01-03 |
| K884391 | PREMET, METAL PRIMER | Scientific Pharmaceuticals, Inc. | EBF | Class II | 1989-01-03 |
| K884575 | MAXIBOND | Ortho Source | DYH | Class II | 1989-01-03 |
| K884350 | UNIREST COMPOSITE RESTORATIVE, SELF CURED | Scientific Pharmaceuticals, Inc. | EBF | Class II | 1989-01-03 |
| K884351 | UNIREST PL, ANTE./POST. RESTORATIVE, PASTE/LIQUID | Scientific Pharmaceuticals, Inc. | EBF | Class II | 1988-12-28 |
| K884277 | AD POST | J. Morita USA, Inc. | ELR | Class I | 1988-12-22 |
| K884187 | INDENTEC DRILL RA #1 | Phillip C. Crawford, D.D.S. | DZA | Class I | 1988-12-22 |
| K884316 | OCCLUSAL HARMONY IMPRESSION TRAY | Advantage Dental Co. | EHY | Class I | 1988-12-22 |
| K884352 | SMILE-DENT ANTE./POST. RESTORATIVE, LIGHT-CURED | Scientific Pharmaceuticals, Inc. | EBF | Class II | 1988-12-22 |
| K884257 | LEVINIUM | Ticomet Engineering & Consulting | EJH | Class II | 1988-12-22 |
| K883354 | VARIABLE KV INTREX VSK 60 - 90 KVP | Keystone X-Ray, Inc. | EAP | Class II | 1988-12-21 |
| K882526 | DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR. | Aseptico, Inc. | EIA | Class I | 1988-12-08 |
| K883922 | TECHMEDICA I.B.O. BLADE | Techmedica, Inc. | DZJ | Class II | 1988-12-08 |
| K884214 | CRYSTAR(TM) VINTAGE PORCELAIN | Shofu Dental Corp. | ELL | Class II | 1988-12-08 |
| K884523 | MARTIN-CHAMPY TITAN SET | Buschmann Surgical Products | JEY | Class II | 1988-12-08 |
| K884137 | MIRAGE BOND | Chameleon Dental Products, Inc. | KLE | Class II | 1988-12-07 |
| K884038 | FIBERLITE, FIBERLITE HS AND FIBERSEAL | Jeneric/Pentron, Inc. | EBF | Class II | 1988-12-07 |
| K883904 | APOLLO VS, VT, VR 1000/1500, FREEDOM HS, HT, HR | Apollo Dental Products, Inc. | EIA | Class I | 1988-12-07 |
| K884475 | CHELON-FIL | Espe GmbH (Us) | EMA | Class II | 1988-12-05 |
| K883761 | IONODENT II (6 VOLTS) | U.S. Apatite Corp. | EFW | Class I | 1988-12-05 |
| K884081 | INTERIM, TEMPORARY CEMENT | Scientific Pharmaceuticals, Inc. | EMA | Class II | 1988-12-02 |
| K883770 | RESUBMITTED EMA DENTIN CEMENT | G-C Intl. Corp. | EMA | Class II | 1988-11-30 |
| K882751 | GLASS IONOMER BASE | Dentsply Intl. | EJK | Class II | 1988-11-29 |
| K883698 | ZINC OXIDE EUGENOL TEMPORARY CEMENT | E&D Dental Manufacturing Co. | EMA | Class II | 1988-11-29 |
| K880371 | BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINER | American Biomaterials Corp. | LYC | Class II | 1988-11-18 |
| K883211 | IMZ O-RING ATTACHMENT | Interpore Intl. | DZE | Class II | 1988-11-17 |
| K883120 | FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE | Flexmedics | EJF | Class I | 1988-11-14 |
| K884418 | PREMIER DIE-TRAK ARTICULATOR | Premier Medical | EJP | Class I | 1988-11-14 |
| K884357 | PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM | Precision Dynamics Corp. | KOT | Class I | 1988-11-01 |
| K881422 | COE PAK AUTO MIX, REGULAR OR HARD SET | Coe Laboratories, Inc. | EMA | Class II | 1988-10-31 |
| K883403 | DENTA PLUS | Connoisseurs Products Corp. | JER | Class I | 1988-10-25 |
| K883799 | BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN | Austenal Dental, Inc. | EBI | Class II | 1988-10-20 |
| K884145 | FLOSER PLUS | Pacific Lin Intl., Co. | JES | Class I | 1988-10-19 |
| K882532 | STAR ALLOYS, LITE ALLOYS AND BRITE ALLOYS | Five Stars Alloys , Ltd. | EJT | Class II | 1988-10-19 |
| K882566 | VISIO-PERL | Espe GmbH (Us) | EBF | Class II | 1988-10-19 |
| K874416 | DENTAL ANTI-SNORING DEVICE | Ortho Publications, Inc. | LRK | Class II | 1988-10-18 |
| K883392 | LUMINBOND, BONDING AND CEMENTATION SYSTEM | Scientific Pharmaceuticals, Inc. | EBF | Class II | 1988-10-18 |
| K883775 | PORTABLE II DENTAL DELIVERY SYSTEM | Dntl Corp. | EIA | Class I | 1988-10-14 |
| K882695 | RUBBER BAND, STERILE | Bioseal | ECI | Class I | 1988-10-13 |
| K883465 | ORTHO-SEAL | Bisco, Inc. | DYH | Class II | 1988-10-12 |
| K882571 | KOLYNOS DENTAL FLOSS | Whitehall Laboratories, Inc. | JES | Class I | 1988-10-12 |
| K883758 | ALBABOND 60 | Degussa Dental, Inc. | EJT | Class II | 1988-10-12 |
| K883437 | DENTAL CHAIR | E.F. Brewer Co. | KLC | Class I | 1988-10-12 |
| K883388 | DENTREK BRIDGE BARS | Dale T. Dupuis | EHO | Class I | 1988-10-06 |
| K883511 | ALBABOND E | Degussa Dental, Inc. | EJS | Class II | 1988-10-06 |
| K883126 | BREVET DENTAL INSTRUMENTS | Brevet, Inc. | EKJ | Class I | 1988-10-05 |
| K880475 | SKEMA (DENTAL UNIT) | Alpine Dental Equipment Co. | KLC | Class I | 1988-09-23 |
| K882800 | COLTENE PRESIDENT JET REGULAR BODY | Coltene, Inc. | ELW | Class II | 1988-09-23 |
| K880474 | AREA (DENTAL CHAIR) | Alpine Dental Equipment Co. | KLC | Class I | 1988-09-23 |
| K883509 | HERAEUS DG 63 | Degussa Dental, Inc. | EJS | Class II | 1988-09-22 |
| K883508 | HERA H | Degussa Dental, Inc. | EJT | Class II | 1988-09-22 |
| K883325 | PERFORMED CROWN (STAINLESS STEEL) | Whitecap Dental Co. | ELZ | Class I | 1988-09-16 |
| K882821 | VITRABOND LIGHT CURE GLASS IONOMER LINER | 3M Company | EKJ | Class I | 1988-09-15 |
| K883510 | DEGUPAL 4 | Degussa Dental, Inc. | EJS | Class II | 1988-09-15 |
| K883507 | HERAEUS C SPECIAL | Degussa Dental, Inc. | EJS | Class II | 1988-09-15 |
| K882379 | MINIM-X 2001-CIAS & MINIM-X 2002-CIAS | Dentomar, Inc. | EAP | Class II | 1988-09-09 |
| K882145 | PHOTO-CURING LIGHT | Dentsply Intl. | EBZ | Class II | 1988-09-06 |
| K883512 | HERAEUS WHITE | Degussa Dental, Inc. | EJS | Class II | 1988-09-06 |
| K881662 | EXPANDED CLAIMES TO OSTEOGEN(R) | Impladent | DZE | Class II | 1988-09-01 |
| K883225 | FLOSSIE | Richard G. Deniro | JET | Class I | 1988-08-30 |
| K882226 | SERIES I AND II IMPLANTS | Saber Technology, Inc. | DZE | Class II | 1988-08-29 |
| K883335 | COLGATE DENTAL FLOSS | Colgate-Palmolive Co. | JES | Class I | 1988-08-26 |
| K883322 | DENTAL HAND INSTRUMENTS | Collagen Corp. | EKJ | Class I | 1988-08-26 |
| K881391 | ULTRASONIC DENTURE CLEANER | Tatung Company of America, Inc. | JER | Class I | 1988-08-26 |
| K882491 | CUTTING FLUID SYSTEM FOR DENTAL HIGH SPEED DRILLS | Steri-Sol, Inc. | EFB | Class I | 1988-08-26 |
| K883024 | ORAL-B FLOSSERS | Oral-B Laboratories | JES | Class I | 1988-08-26 |
| K881826 | ENDO-ICE | The Hygenic Corp. | EAT | Class II | 1988-08-23 |
| K880562 | ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT | Macrochem Corp. | DYH | Class II | 1988-08-19 |
| K882828 | DENTAL FLOSS PICK | Bik Pik | JES | Class I | 1988-08-12 |
| K882759 | PROFESSIONAL MODEL 7525 DELIVERY SYSTEM | Viadent | EFS | Class I | 1988-08-12 |
| K882578 | ASTRA DENTAL IMPLANT SYSTEM | Astra Meditec AB | DZE | Class II | 1988-08-12 |
| K882482 | TRIAD ORTHODONTIC GEL | Dentsply Intl. | EBI | Class II | 1988-08-12 |
| K883036 | PALLIAG NF III | Degussa Dental, Inc. | EJT | Class II | 1988-08-12 |
| K882915 | FORTIFY | Bisco, Inc. | EBF | Class II | 1988-08-12 |
| K882810 | EASY-OP, PORTABLE DENTAL CART | Wy'East Medical Corp. | EIA | Class I | 1988-08-12 |
| K882690 | IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL | 3M Company | ELW | Class II | 1988-08-11 |
| K882125 | CENTRIX TRI-LAMINATE POST SYSTEM | Centrix, Inc. | ELR | Class I | 1988-08-11 |
| K882651 | CENTRIX NEEDLETUBE | Centrix, Inc. | EKJ | Class I | 1988-08-10 |
| K883074 | ELGILOY | Dale T. Dupuis | EBL | Class I | 1988-08-09 |
| K882436 | LASER - 1000 | Panoramic Corp. | EHD | Class II | 1988-08-04 |
| K882834 | TISSUE PUNCH | Tri-Stage, Inc. | EKJ | Class I | 1988-08-02 |
| K881838 | MODIFIED PERMAGUM ADHESIVE | Espe GmbH (Us) | EBH | Class I | 1988-07-27 |
| K881992 | SYRETTE | Oratec Corp. | EKJ | Class I | 1988-07-26 |
| K881974 | PROFICIENT(TM) PROPHYLAXIS ANGLE | Block Drug Company, Inc. | EFB | Class I | 1988-07-25 |
| K881985 | CONTRA ANGLE HANDPIECE ATTACH. W/PROPHYLAXIS CUP | Denticator | EFB | Class I | 1988-07-25 |
| K881245 | DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER | Cadco Dental Products, Inc. | EBI | Class II | 1988-07-21 |
| K874443 | IONODENT (TOOTHBRUSH) | U.S. Apatite Corp. | EFW | Class I | 1988-07-19 |
| K881918 | LIGHT-CURED ZIONOMER CEMENT | Den-Mat Corp. | EMA | Class II | 1988-07-15 |
| K882400 | AMORPHUS SILK BY DENTRAX | Dale T. Dupuis | EBF | Class II | 1988-07-15 |
| K881890 | PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT | Specialites Septodont | EMA | Class II | 1988-07-15 |
| K881914 | COVER UP | Parkell | EMA | Class II | 1988-07-15 |
| K880940 | AMDENT MODEL 830 ULTRASONIC SCALER | Pathway Products, Inc. | ELC | Class II | 1988-07-15 |
| K882576 | ACID ETCH GEL | Pulpdent Corp. of America | EBF | Class II | 1988-07-15 |
| K880741 | ESPE VARNISH | Espe GmbH (Us) | LBH | Class II | 1988-07-01 |
12,679 clearances in the Dental panel. Data: openFDA.