FDA Product Code
FDA Product Code EBF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3690
510(k) Clearances — 937 records · page 7 of 10
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K942767 | ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN | Wallace A. Erickson & Co. | 1994-07-08 | Traditional | PDF ↗ |
| K941899 | SDI COMPOSTIES | Southern Dental Industries, Inc. | 1994-07-05 | Traditional | PDF ↗ |
| K942031 | CAULK TOOTH CONDITIONER GEL AND SYRINGE | Dentsply Intl. | 1994-06-10 | Traditional | PDF ↗ |
| K940737 | EDTA GEL (TM) | Karolinska Institutet | 1994-06-03 | Traditional | PDF ↗ |
| K941377 | CONQUEST SMOOTH TOUCH | Jeneric/Pentron, Inc. | 1994-05-03 | Traditional | PDF ↗ |
| K941373 | PENT CORE PLUS (PASTE-PASTE) | Jeneric/Pentron, Inc. | 1994-05-03 | Traditional | PDF ↗ |
| K941378 | PROCOM | Jeneric/Pentron, Inc. | 1994-05-02 | Traditional | PDF ↗ |
| K941374 | CONQUEST PRELUDE | Jeneric/Pentron, Inc. | 1994-05-02 | Traditional | PDF ↗ |
| K941376 | CONQUEST SENIOR | Jeneric/Pentron, Inc. | 1994-05-02 | Traditional | PDF ↗ |
| K941375 | CONQUEST GINGA-BLEND | Jeneric/Pentron, Inc. | 1994-05-02 | Traditional | PDF ↗ |
| K940800 | DENTACOLOR VITA (VS) SHADE SYSTEM | Heraeus Kulzer, Inc. | 1994-04-07 | Traditional | PDF ↗ |
| K930583 | MEGABOND SYSTEM | Scientific Pharmaceuticals, Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K930584 | MAGNACORE | Scientific Pharmaceuticals, Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K932828 | CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE | Alpha-Dent | 1994-02-03 | Traditional | PDF ↗ |
| K932829 | CENTRIX'S ENCORE NATURAL COMPOSITE RESIN CORE PAST | Alpha-Dent | 1994-01-28 | Traditional | PDF ↗ |
| K932826 | CENTRIX'S ENCORE COMPOSITE RESIN CORE PASTE W\FLUO | Alpha-Dent | 1994-01-28 | Traditional | PDF ↗ |
| K922251 | TI-CORE-NATURAL | Essential Dental Systems, Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K935736 | CHARISMA SUPERLIGHT | Heraeus Kulzer, Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K922252 | TI-CORE NEW & IMPROVED | Essential Dental Systems, Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K933766 | HIGH-Q-BOND | Silmet U.S.A. Corp. | 1994-01-26 | Traditional | PDF ↗ |
| K935032 | ZENITH TOTAL ETCH 10% PHOSPHORIC ACID | Foremost Dental Mfg., Inc. | 1994-01-18 | Traditional | PDF ↗ |
| K934247 | BISCO UNIVERSAL HYBRID COMPOSITE | Bisco, Inc. | 1993-11-29 | Traditional | PDF ↗ |
| K933656 | JEDENTAL PSROFILL SELF-CURE COMPOSITE | Jedental Co., Inc. | 1993-11-17 | Traditional | PDF ↗ |
| K934611 | STO2P | Ivoclar North America, Inc. | 1993-11-17 | Traditional | PDF ↗ |
| K930128 | SR SPECTRASIT, SR CHROMASIT | Ivoclar North America, Inc. | 1993-10-07 | Traditional | PDF ↗ |
| K932886 | ALPHA-DENT LIGHT ACTIVATED CORE BUILDUP BLUE PASTE | Wallace A. Erickson & Co. | 1993-09-29 | Traditional | PDF ↗ |
| K932827 | ALPHA-DENT CORE BUILDUP PASTE | Alpha-Dent | 1993-09-23 | Traditional | PDF ↗ |
| K932154 | CONQUEST CRYSTAL | Jeneric/Pentron, Inc. | 1993-09-15 | Traditional | PDF ↗ |
| K932227 | AMELOGEN RESTORATIVE MATERIALS | Ultradent Products, Inc. | 1993-09-13 | Traditional | PDF ↗ |
| K932793 | PULPDENT 2.5% NITRIC ACID ETCHANT | Pulpdent Corp. | 1993-09-13 | Traditional | PDF ↗ |
| K932792 | PULPDENT MALEIC ACID ETCHANTS | Pulpdent Corp. | 1993-09-09 | Traditional | PDF ↗ |
| K931867 | ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE | Ultradent Products, Inc. | 1993-09-09 | Traditional | PDF ↗ |
| K932395 | VLC DR MATERIAL | Dentsply Intl. | 1993-08-25 | Traditional | PDF ↗ |
| K930405 | BISCO D/C CORE COMPOSITE | Bisco, Inc. | 1993-08-24 | Traditional | PDF ↗ |
| K931309 | VARIOLINK | Ivoclar North America, Inc. | 1993-07-22 | Traditional | PDF ↗ |
| K931880 | PROFILL LC COMPOSITE | Jedental Co., Inc. | 1993-07-08 | Traditional | PDF ↗ |
| K932013 | CHARISMA -- MODIFIED | Heraeus Kulzer, Inc. | 1993-07-08 | Traditional | PDF ↗ |
| K924727 | 100 LIGHT CURE UNIT | Rolence Enterprise Co. , Ltd. | 1993-06-17 | Traditional | PDF ↗ |
| K920533 | DENTIN BONDING AGENT | Confi-Dental Products Co. | 1993-05-19 | Traditional | PDF ↗ |
| K926556 | VIVALUX | Ivoclar North America, Inc. | 1993-04-23 | Traditional | PDF ↗ |
| K926418 | CLIP | Voco GmbH | 1993-03-31 | Traditional | PDF ↗ |
| K925162 | MICRODOSE DENTIN CONDITIONER | Unicep | 1993-03-16 | Traditional | PDF ↗ |
| K926074 | PULPDENT DENTAL BOND ENCHANCER | Pulpdent Corp. | 1993-03-16 | Traditional | PDF ↗ |
| K924826 | MICRODOSE TOTAL ETCHANT | Unicep | 1993-03-05 | Traditional | PDF ↗ |
| K924822 | MICRODOSE ENAMEL ETCHANT | Unicep | 1993-03-05 | Traditional | PDF ↗ |
| K925383 | PHOTO CLEARFIL OPAQUER | Kuraray Co. | 1993-01-28 | Traditional | PDF ↗ |
| K924151 | BISCO D/C RESINOMER | Bisco, Inc. | 1992-12-28 | Traditional | PDF ↗ |
| K923472 | COMPACOLOR | Wilde-USA, Inc. | 1992-10-13 | Traditional | PDF ↗ |
| K923867 | METAFIL | Parkell | 1992-10-06 | Traditional | PDF ↗ |
| K923236 | TRIAD INLAY COMPOSITE | Dentsply Intl. | 1992-09-11 | Traditional | PDF ↗ |
| K921602 | ULTRADENT PRODUCT TOOTH SURFACE DRYING AGENT | Ultradent Products, Inc. | 1992-09-09 | Traditional | PDF ↗ |
| K921409 | ENAMEL AND PORCELAIN ETCH PRODUCT LINE | Ultradent Products, Inc. | 1992-09-09 | Traditional | PDF ↗ |
| K921407 | COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE | Ultradent Products, Inc. | 1992-09-09 | Traditional | PDF ↗ |
| K921598 | ULTRADENT PRODUCT PIT & FISSURE SEALANT PROD LINE | Ultradent Products, Inc. | 1992-09-09 | Traditional | PDF ↗ |
| K920892 | LITE FIL II A | Shofu Dental Corp. | 1992-09-01 | Traditional | PDF ↗ |
| K920893 | LITE FILL II P | Shofu Dental Corp. | 1992-09-01 | Traditional | PDF ↗ |
| K921174 | COMPOSITE RESIN CORE PASTE MATERIAL | Centrix, Inc. | 1992-09-01 | Traditional | PDF ↗ |
| K922755 | PULPDENT HARD CORE | Pulpdent Corp. | 1992-08-20 | Traditional | PDF ↗ |
| K922569 | TETRIC LIGHT-CURING COMPOSITE | Ivoclar North America, Inc. | 1992-07-15 | Traditional | PDF ↗ |
| K921820 | RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION | Cosmedent, Inc. | 1992-06-16 | Traditional | PDF ↗ |
| K921439 | BISCO CORE PASTE | Bisco, Inc. | 1992-05-11 | Traditional | PDF ↗ |
| K920483 | 10% PHOSPHORIC ACID ETCHING GEL | Pulpdent Corp. | 1992-04-29 | Traditional | PDF ↗ |
| K920485 | PUPLDENT ETCH N PREP | Pulpdent Corp. | 1992-04-29 | Traditional | PDF ↗ |
| K920482 | 14% HYDROFLUORIC ACID ETCHING GEL | Pulpdent Corp. | 1992-04-28 | Traditional | PDF ↗ |
| K920484 | 2.5% NITRIC ACID ETCHING GEL | Pulpdent Corp. | 1992-04-28 | Traditional | PDF ↗ |
| K915668 | BISCO CAVITY CLEANSER | Bisco, Inc. | 1992-04-21 | Traditional | PDF ↗ |
| K913089 | WILDE LIGHT CURING COMPOSITE RESTORATIVE RESINS | Wilde-USA, Inc. | 1992-04-21 | Traditional | PDF ↗ |
| K920425 | 3M BRAND RESTORATIVE Z100 | 3M Company | 1992-03-20 | Traditional | PDF ↗ |
| K920365 | TOOTH BONDING AGENT | Voco GmbH | 1992-03-19 | Traditional | PDF ↗ |
| K914456 | DENTACOLOR(R) CRE-ACTIVE | Heraeus Kulzer, Inc. | 1992-03-11 | Traditional | PDF ↗ |
| K915336 | TWINLOOK | Heraeus Kulzer, Inc. | 1992-02-03 | Traditional | PDF ↗ |
| K913200 | GTI CLASP COVER | Gti, Inc. | 1992-02-03 | Traditional | PDF ↗ |
| K915355 | ADS-GEL AND INSULATING-GEL | Heraeus Kulzer, Inc. | 1992-01-31 | Traditional | PDF ↗ |
| K915335 | SILICOATER SYSTEM | Heraeus Kulzer, Inc. | 1992-01-21 | Traditional | PDF ↗ |
| K913966 | SONO(R) -CEM | Espe GmbH (Us) | 1992-01-14 | Traditional | PDF ↗ |
| K913947 | IMPERVA BOND | Shofu Dental Corp. | 1991-10-09 | Traditional | PDF ↗ |
| K913100 | PALFIQUE INLAY | Tokuyama America, Inc. | 1991-10-02 | Traditional | PDF ↗ |
| K913099 | PALFIQUE LITEPOSTERIOR | Tokuyama America, Inc. | 1991-10-02 | Traditional | PDF ↗ |
| K912788 | CURAY SUPPORT | Scientific Pharmaceuticals, Inc. | 1991-08-23 | Traditional | PDF ↗ |
| K912708 | CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM | Kuraray Co. | 1991-08-20 | Traditional | PDF ↗ |
| K912037 | DEGULUX LIGHT CURING UNIT | Degussa AG | 1991-06-07 | Traditional | PDF ↗ |
| K910263 | CHARISMA | Kulzer, Inc. | 1991-06-03 | Traditional | PDF ↗ |
| K904813 | VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT. | Alpha-Dent | 1991-05-31 | Traditional | PDF ↗ |
| K910627 | ALPHA-FIL, ALPHA-BASE & ALPHA-SILVER, MODIFICATION | Foremost Mfg., Inc. | 1991-05-29 | Traditional | PDF ↗ |
| K911524 | PALFIQUE ESTELITE | Tokuyama America, Inc. | 1991-05-29 | Traditional | PDF ↗ |
| K904805 | TENTATIVE OPERATING NAME-JAZZ BAND | Franklin M. Din D.M.D., P.A. | 1991-03-29 | Traditional | PDF ↗ |
| K905604 | VISIO-GEM ART-SYSTEM | Espe GmbH (Us) | 1991-03-29 | Traditional | PDF ↗ |
| K905131 | DURAFILL COLOR VS | Kulzer, Inc. | 1991-03-15 | Traditional | PDF ↗ |
| K904812 | COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE | Alpha-Dent | 1991-02-26 | Traditional | PDF ↗ |
| K905476 | STOMADENT TM | Dentsply Intl. | 1991-02-20 | Traditional | PDF ↗ |
| K905220 | MONOBOND S | Ivoclar North America, Inc. | 1990-12-17 | Traditional | PDF ↗ |
| K903481 | ALPHA-FILL, ALPHA-CEM, AND ALPHA-SILVER | Dental Foremost | 1990-12-17 | Traditional | PDF ↗ |
| K905221 | SPECIAL BOND II | Ivoclar North America, Inc. | 1990-12-17 | Traditional | PDF ↗ |
| K904555 | DURAFILL FLOW | Kulzer, Inc. | 1990-11-13 | Traditional | PDF ↗ |
| K901260 | CORADENT | Ivoclar North America, Inc. | 1990-10-22 | Traditional | PDF ↗ |
| K903587 | HELIOLINK TRY-IN PASTES | Ivoclar North America, Inc. | 1990-10-09 | Traditional | PDF ↗ |
| K902040 | ALTIS (RESIN, CROWN AND BRIDGES) | Pb2 Investment, Inc. | 1990-10-09 | Traditional | PDF ↗ |
| K903551 | TEMPOREX | Scientific Pharmaceuticals, Inc. | 1990-10-05 | Traditional | PDF ↗ |
| K902893 | TI-CORE (DENTAL COMPOSITE) | Medical Device Inspection Co., Inc. | 1990-09-06 | Traditional | PDF ↗ |
| K902402 | HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE | Dentalez Group | 1990-08-29 | Traditional | PDF ↗ |
Product code EBF · Class II · Dental. Data: openFDA.