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 6 of 10
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K982148 | PRODIGY 2 | Sybron Dental Specialties, Inc. | 1998-07-31 | Traditional | PDF ↗ |
| K981562 | SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT | Sulzer Calcitek, Inc. | 1998-07-30 | Traditional | PDF ↗ |
| K981813 | PERMACEM AUTOMIX LUTING CEMENT SYSTEM | Foremost Dental Mfg., Inc. | 1998-07-10 | Traditional | PDF ↗ |
| K981264 | ARISTON PHC | Ivoclar USA, Inc. | 1998-07-02 | Traditional | PDF ↗ |
| K980018 | CRISTOBAL | Newave Medical, Inc. | 1998-05-19 | Traditional | PDF ↗ |
| K980792 | CU-100A LIGHT CURE UNIT | Rolence Enterprise Co. , Ltd. | 1998-05-15 | Traditional | PDF ↗ |
| K980793 | Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT | Rolence Enterprise Co. , Ltd. | 1998-05-15 | Traditional | PDF ↗ |
| K980058 | TOKUSO MAC BOND II | Tokuyama America, Inc. | 1998-04-27 | Traditional | PDF ↗ |
| K980054 | PALFIQUE ESTELITE | Tokuyama America, Inc. | 1998-04-27 | Traditional | PDF ↗ |
| K974465 | SYNERGY | Coltene/Whaledent, Inc. | 1998-03-09 | Traditional | PDF ↗ |
| K980051 | PALFIQUE ESTELITE PASTE | Tokuyama America, Inc. | 1998-02-24 | Traditional | PDF ↗ |
| K974483 | NTL-FLOW | Bisco, Inc. | 1998-02-09 | Traditional | PDF ↗ |
| K973221 | COMPOSITE 168 RESTORATIVE SYSTEM | Dentsply Intl. | 1998-02-09 | Traditional | PDF ↗ |
| K973235 | DYRACT AP RESTORATIVE | Dentsply Intl. | 1998-02-05 | Traditional | PDF ↗ |
| K974413 | PERMAFLO | Ultradent Products, Inc. | 1998-02-02 | Traditional | PDF ↗ |
| K974577 | COMPOGLASS FLOW | Ivoclar North America, Inc. | 1998-01-30 | Traditional | PDF ↗ |
| K974282 | VITALESCENCE | Ultradent Products, Inc. | 1998-01-29 | Traditional | PDF ↗ |
| K974105 | KERR COMPOMER | Sybron Dental Specialties, Inc. | 1998-01-09 | Traditional | PDF ↗ |
| K973513 | SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER | Espe GmbH & Co. Kg. | 1997-12-22 | Traditional | PDF ↗ |
| K974131 | ALERT | Jeneric/Pentron, Inc. | 1997-12-17 | Traditional | PDF ↗ |
| K973089 | FREEDOM | Southern Dental Industries, Inc. | 1997-12-08 | Traditional | PDF ↗ |
| K973091 | WAVE | Southern Dental Industries, Inc. | 1997-12-08 | Traditional | PDF ↗ |
| K973976 | EPIC-FLO | Parkell, Inc. | 1997-12-04 | Traditional | PDF ↗ |
| K973257 | VERSAETCH | Centrix, Inc. | 1997-11-17 | Traditional | PDF ↗ |
| K972292 | SOLIDEX | Shofu Dental Corp. | 1997-10-29 | Traditional | PDF ↗ |
| K972892 | CAVIT-LC | Espe GmbH & Co. Kg. | 1997-10-02 | Traditional | PDF ↗ |
| K971594 | FLOW-RITE | Pulpdent Corp. | 1997-09-12 | Traditional | PDF ↗ |
| K971762 | BELLEGLASS HP ENAMEL REPAIR MATERIAL | Sybron Dental Specialties, Inc. | 1997-09-12 | Traditional | PDF ↗ |
| K970683 | ZENTIH FLOWABLE COMPOSITE (MULTIPLE) | Foremost Dental Mfg., Inc. | 1997-07-15 | Traditional | PDF ↗ |
| K971898 | PERMALUTE, TRY-IN PASTE | Ultradent Products, Inc. | 1997-06-24 | Traditional | PDF ↗ |
| K971513 | COMPOGLASS F | Ivoclar North America, Inc. | 1997-06-03 | Traditional | PDF ↗ |
| K971372 | VARIOLINK II | Ivoclar North America, Inc. | 1997-05-29 | Traditional | PDF ↗ |
| K970500 | 3M SUSTEL DENTAL SYSTEM | 3M Company | 1997-04-30 | Traditional | PDF ↗ |
| K970495 | FOUNDATION INDIRECT COMPOSITE RESIN | Sybron Dental Specialties, Inc. | 1997-04-16 | Traditional | PDF ↗ |
| K970246 | EDTA CAVIT | Karolinski | 1997-04-16 | Traditional | PDF ↗ |
| K962376 | KREATIV KURING LIGHT SYSTEM | Kreativ, Inc. | 1997-03-21 | Traditional | PDF ↗ |
| K964931 | WHITE CORE | Bisco, Inc. | 1997-02-10 | Traditional | PDF ↗ |
| K965060 | ULTRA-ETCH STAT | Ultradent Products, Inc. | 1997-01-31 | Traditional | PDF ↗ |
| K964285 | TETRIC CERAM | Ivoclar North America, Inc. | 1997-01-22 | Traditional | PDF ↗ |
| K964179 | SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS | S.S. White Mfg., Ltd. | 1997-01-09 | Traditional | PDF ↗ |
| K964578 | FIBREKOR | Jeneric/Pentron, Inc. | 1996-12-03 | Traditional | PDF ↗ |
| K963735 | COJET SYSTEM | Espe GmbH & Co. Kg. | 1996-11-27 | Traditional | PDF ↗ |
| K963805 | PRODIGY AC | Sybron Dental Specialties, Inc. | 1996-11-27 | Traditional | PDF ↗ |
| K963652 | PULPDENT DESENSITIZER | Pulpdent Corp. | 1996-10-11 | Traditional | PDF ↗ |
| K963311 | TEAM ETCH | Centrix, Inc. | 1996-10-07 | Traditional | PDF ↗ |
| K962909 | DENTAL PREP WASH AND PREP DISINFECT | William J. Day | 1996-10-07 | Traditional | PDF ↗ |
| K962878 | TARGIS SYSTEM | Ivoclar North America, Inc. | 1996-09-25 | Traditional | PDF ↗ |
| K962440 | PERTAC II/PERTAC II APLITIP | Espe GmbH & Co. Kg. | 1996-09-11 | Traditional | PDF ↗ |
| K962442 | HYTAC APLITIP/HYTAC OSB | Espe GmbH & Co. Kg. | 1996-09-11 | Traditional | PDF ↗ |
| K962192 | SUNRISE CURING LAMP | Sunrise Technologies, Inc. | 1996-09-03 | Traditional | PDF ↗ |
| K962405 | SANICURE DISPOSABLE CURING PROBE | Efos Canada, Inc. | 1996-08-29 | Traditional | PDF ↗ |
| K961434 | VITA ZETA CROWN AND BRIDGE ACRYLIC VENEERING SYSTEM | Vident | 1996-07-08 | Traditional | PDF ↗ |
| K960667 | CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE | Wallace A. Erickson & Co. | 1996-07-02 | Traditional | PDF ↗ |
| K961284 | KOLOR + | Sybron Dental Specialties, Inc. | 1996-05-08 | Traditional | PDF ↗ |
| K960729 | ENAMEL CONDITIONER (ENAMEL ETCHING AGENT) | Dent Zar, Inc. | 1996-04-26 | Traditional | PDF ↗ |
| K960598 | CONCORD MARYLAND BRIDGE CEMENT | Dent Zar, Inc. | 1996-04-26 | Traditional | PDF ↗ |
| K960595 | FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETS | Dent Zar, Inc. | 1996-04-26 | Traditional | PDF ↗ |
| K960597 | ORION-1 VL CROWN BASE AND POST CEMENT VISIBLE LIGHT CURE | Dent Zar, Inc. | 1996-04-26 | Traditional | PDF ↗ |
| K960594 | LIGHT SUPER BOND-1 LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND CERAMIC BRACKETS | Dent Zar, Inc. | 1996-04-26 | Traditional | PDF ↗ |
| K960599 | SUPERIOR PHOTOCURING HYBRID COMPOSITE | Dent Zar, Inc. | 1996-04-26 | Traditional | PDF ↗ |
| K960596 | ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE | Dent Zar, Inc. | 1996-04-26 | Traditional | PDF ↗ |
| K960600 | LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS | Dent Zar, Inc. | 1996-04-26 | Traditional | PDF ↗ |
| K960565 | ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE | Dent Zar, Inc. | 1996-03-22 | Traditional | PDF ↗ |
| K960165 | ALPHA-DENT COMPOSITE SURFACE SEALANT | Wallace A. Erickson & Co. | 1996-03-15 | Traditional | PDF ↗ |
| K954988 | CRYSTALLESSENCE | Confi-Dental Products Co. | 1996-03-08 | Traditional | PDF ↗ |
| K955337 | OPAKER | Kerr Dental Materials Center | 1996-01-23 | Traditional | PDF ↗ |
| K955292 | AELITEFLO | Bisco, Inc. | 1995-12-13 | Traditional | PDF ↗ |
| K954929 | CHARISMA SINGLE DOSE | Heraeus Kulzer, Inc. | 1995-11-27 | Traditional | PDF ↗ |
| K954408 | AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE BUILDUP BLUE PASTEE | American Dental Products, Inc. | 1995-10-30 | Traditional | PDF ↗ |
| K954405 | AMERICAN DENTAL PRODDUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE PASTE WITH FLUORIDE | American Dental Products, Inc. | 1995-10-30 | Traditional | PDF ↗ |
| K954406 | AMERICAN DENTAL PRODUCTS COMPOSITE RESIN CORE PASTE WITH FLUORIDE | American Dental Products, Inc. | 1995-10-30 | Traditional | PDF ↗ |
| K954407 | AMERICAN DENTAL PRODUCTS WHITE COMPOSITE RESIN CORE PASTE WITH FLUORIDE | American Dental Products, Inc. | 1995-10-30 | Traditional | PDF ↗ |
| K954461 | AMERICAN DENTAL PRODUCTS CORE BUILDUP PASTE | American Dental Products, Inc. | 1995-10-16 | Traditional | PDF ↗ |
| K954115 | ARTGLASS & KEVLOC | Heraeus Kulzer, Inc. | 1995-09-27 | Traditional | PDF ↗ |
| K952662 | COMP=FLOW | Jeneric/Pentron, Inc. | 1995-08-28 | Traditional | PDF ↗ |
| K953525 | ULTRADENT FLOWABLE COMPOSITE | Ultradent Products, Inc. | 1995-08-28 | Traditional | PDF ↗ |
| K952333 | PLASMA ARC CURING SYSTEM | American Dental Technologies, Inc. | 1995-08-10 | Traditional | PDF ↗ |
| K952353 | EZ-COMP | Adm, Inc. | 1995-08-10 | Traditional | PDF ↗ |
| K952500 | COMPSEAL | Jeneric/Pentron, Inc. | 1995-06-22 | Traditional | PDF ↗ |
| K951836 | COMPOLGLASS COMPOGLASS SCA | Ivoclar North America, Inc. | 1995-05-25 | Traditional | PDF ↗ |
| K951427 | AMERICAN DENTAL PRODUCTS (ADP), COMPOSITE RESTORATIVE MATERIAL | American Dental Products, Inc. | 1995-05-15 | Traditional | PDF ↗ |
| K951426 | AMERICAN DENTAL PRODUCTS (ADP), VISIBLE LIGHT CURE COMPOSITE DENTAL RESTORATIVE MATERIAL | American Dental Products, Inc. | 1995-05-12 | Traditional | PDF ↗ |
| K950859 | PERMASEAL | Ultradent Products, Inc. | 1995-03-23 | Traditional | PDF ↗ |
| K950991 | DYRACT II RESTORATIVE | Dentsply Intl. | 1995-03-23 | Traditional | PDF ↗ |
| K950765 | COMPA LAB-R | Robert W. Bauer & Assoc., Inc. | 1995-03-13 | Traditional | PDF ↗ |
| K942993 | THERMORESIN LC II | GC America, Inc. | 1995-02-07 | Traditional | PDF ↗ |
| K946307 | CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE | Confi-Dental Products Co. | 1995-01-26 | Traditional | PDF ↗ |
| K945364 | DYRACT(TM) MATERIAL | Denstply Detrey-Dedent | 1994-12-29 | Traditional | PDF ↗ |
| K945539 | OPTIGUARD | Sybron Dental Specialties, Inc. | 1994-12-29 | Traditional | PDF ↗ |
| K945769 | TOTAL ETCH GEL | Dentsply Intl. | 1994-12-29 | Traditional | PDF ↗ |
| K945173 | PULPDENT HARDSHELL | Pulpdent Corp. | 1994-12-15 | Traditional | PDF ↗ |
| K945056 | PULPDENT RESIN CEMENT | Pulpdent Corp. | 1994-12-14 | Traditional | PDF ↗ |
| K945113 | PULPDENT CERVICAL RESTORATIVE | Pulpdent Corp. | 1994-12-14 | Traditional | PDF ↗ |
| K945058 | PULPDENT MICROFILLED ANTERIOR COMPOSITE | Pulpdent Corp. | 1994-12-14 | Traditional | PDF ↗ |
| K945057 | PULPDENT HYBRID ANTERIOR COMPOSITE | Pulpdent Corp. | 1994-12-14 | Traditional | PDF ↗ |
| K945018 | PULPDENT HARD DENTAL POSTERIOR FILLING MATERIAL | Pulpdent Corp. | 1994-12-14 | Traditional | PDF ↗ |
| K944659 | PRODIGY | Sybron Dental Specialties, Inc. | 1994-12-08 | Traditional | PDF ↗ |
| K943642 | HERCULITE XR & XRV | Sybron Dental Specialties, Inc. | 1994-11-17 | Traditional | PDF ↗ |
| K943168 | CLEARFIL AP-X | Kuraray Company, Ltd. | 1994-08-10 | Traditional | PDF ↗ |
| K943169 | CLEARFIL AP-X AND LINER BOND 2 | Kuraray Company, Ltd. | 1994-08-10 | Traditional | PDF ↗ |
Product code EBF · Class II · Dental. Data: openFDA.