FDA Product Code
FDA Product Code EBI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3760
510(k) Clearances — 335 records · page 3 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K984467 | FUSICRYL | Micro Dental Laboratories | 1999-02-24 | Traditional | PDF ↗ |
| K984483 | A-SOFT RELINER | S & C Polymer GmbH | 1999-02-18 | Traditional | PDF ↗ |
| K981862 | RESIN 4 | Harry J. Bosworth Co. | 1999-02-09 | Traditional | PDF ↗ |
| K984341 | STERNVANTAGE VARNISH LC, MODEL 221001 | Sterngold/Implamed | 1999-01-08 | Traditional | PDF ↗ |
| K983547 | PROTECH PLUS | Protech, Inc. | 1999-01-07 | Traditional | PDF ↗ |
| K983876 | MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC | Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind | 1998-12-16 | Traditional | PDF ↗ |
| K983357 | MUCOPREN SOFT RELINING SYSTEM | Roydent Dental Products, Inc. | 1998-11-13 | Traditional | PDF ↗ |
| K981691 | SILICONE SOFT RELINE | Harry J. Bosworth Co. | 1998-11-03 | Traditional | PDF ↗ |
| K982695 | GC RELINE | GC America, Inc. | 1998-10-19 | Traditional | PDF ↗ |
| K981861 | LINER 1:HARD RELINE LIQUID | Harry J. Bosworth Co. | 1998-10-01 | Traditional | PDF ↗ |
| K982537 | TOKUYAMA SOFRELINER | Tokuyama America, Inc. | 1998-08-24 | Traditional | PDF ↗ |
| K981448 | KERR HARD DENTURE RELINE MATERIAL | Sybron Dental Specialties, Inc. | 1998-06-16 | Traditional | PDF ↗ |
| K980616 | PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15) | Kohler Medizintechnik GmbH & Co. KG | 1998-04-30 | Traditional | PDF ↗ |
| K974865 | CSR | Parkell, Inc. | 1998-03-16 | Traditional | PDF ↗ |
| K974160 | BRUXTRAK MATERIAL | Bruxcare, LLC | 1998-03-11 | Traditional | PDF ↗ |
| K974727 | JET ACRYLIC LIQUID-MONOMER, ORTHO JET POWDER-POLYMER, PLASTICIZED METHACRYLATE HOMOPOLYMER, METHACRYLATE COPOLYMER, METR | J.B.C and Co. | 1998-02-24 | Traditional | PDF ↗ |
| K974772 | UFI GEL C | Voco GmbH | 1998-02-10 | Traditional | PDF ↗ |
| K973542 | MASKY | Pressing DI Monticelli Rag. Stefano | 1998-02-10 | Traditional | PDF ↗ |
| K972553 | LANG DENTAL RESIN A97 FIBRED PINK | Lang Dental Mfg. Co., Inc. | 1997-11-13 | Traditional | PDF ↗ |
| K972573 | LIQCRYLIC PRO DENTAL RESIN | Dentsply Intl. | 1997-09-16 | Traditional | PDF ↗ |
| K971138 | DINABASE (TM) | Sultan Chemists, Inc. | 1997-07-21 | Traditional | PDF ↗ |
| K970522 | MYERSON'S ECONOMY DENTURE BASE MATERIAL | Austenal, Inc. | 1997-05-14 | Traditional | PDF ↗ |
| K964040 | TRUBYTE SOFT RELINE SYSTEM | Dentsply Intl. | 1996-12-06 | Traditional | PDF ↗ |
| K963736 | SOFT DENTURE REBASING RESIN | Sybron Dental Specialties, Inc. | 1996-12-04 | Traditional | PDF ↗ |
| K963144 | GC BASELINE | GC America, Inc. | 1996-10-29 | Traditional | PDF ↗ |
| K962333 | V.R.S. DENTURE RESIN MATERIAL | Vident | 1996-08-07 | Traditional | PDF ↗ |
| K962374 | FIBER-SPLINT ML MULTILAYER | Polydentia USA | 1996-07-22 | Traditional | PDF ↗ |
| K961995 | QUICKSPLINT | Heraeus Kulzer, Inc. | 1996-06-26 | Traditional | PDF ↗ |
| K961200 | BOSWORTH LIQUID RESIN II | Harry J. Bosworth Co. | 1996-05-17 | Traditional | PDF ↗ |
| K953589 | TOKUYAMA SOFT RELINING | Tokuyama America, Inc. | 1996-01-18 | Traditional | PDF ↗ |
| K954637 | AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER | American Dental Products, Inc. | 1995-12-28 | Traditional | PDF ↗ |
| K954810 | MYERSON IR DENTURE BASE | Austenal, Inc. | 1995-11-29 | Traditional | PDF ↗ |
| K954689 | CONNECT | Sybron Dental Specialties, Inc. | 1995-10-30 | Traditional | PDF ↗ |
| K953743 | PALASPLINT | Heraeus Kulzer, Inc. | 1995-10-02 | Traditional | PDF ↗ |
| K953381 | PROP. CONQUEST C&B VLC GLAZE/SEALANT | Jeneric/Pentron, Inc. | 1995-09-27 | Traditional | PDF ↗ |
| K953119 | BOSWORTH RESIN II | Bosworth Co. | 1995-08-28 | Traditional | PDF ↗ |
| K952351 | PRECISE DENTURE BASE RESIN | Dentsply Intl. | 1995-07-07 | Traditional | PDF ↗ |
| K944466 | SEALDENT | Scientific Pharmaceuticals, Inc. | 1995-03-02 | Traditional | PDF ↗ |
| K943905 | PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER | Professional Positioners, Inc. | 1995-02-27 | Traditional | PDF ↗ |
| K946317 | HARRY J. BOSWORTH RESIN I. | Harry J. Bosworth Co. | 1995-02-16 | Traditional | PDF ↗ |
| K945711 | EXCEL-P FORMULA AUTO-CURE DENTURE BASE | St. George Technology, Inc. | 1995-02-02 | Traditional | PDF ↗ |
| K942562 | PROSTHOFLEX | Knopf Assoc, Inc. | 1994-12-20 | Traditional | PDF ↗ |
| K941925 | ORTHO-JET ACRYLIC RESIN - SPARKLE | Lang Dental Mfg. Co., Inc. | 1994-05-27 | Traditional | PDF ↗ |
| K940565 | COE-SOFT LC | GC America, Inc. | 1994-05-04 | Traditional | PDF ↗ |
| K935261 | KOOLINER II | GC America, Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K930939 | REBARON LC | GC America, Inc. | 1994-01-21 | Traditional | PDF ↗ |
| K934019 | EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO | St. George Technology, Inc. | 1994-01-18 | Traditional | PDF ↗ |
| K933468 | MYERSON'S PERMASOFT SOFT RELINE MATERIAL | Austenal, Inc. | 1994-01-05 | Traditional | PDF ↗ |
| K934248 | ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER | Wallace A. Erickson & Co. | 1993-12-08 | Traditional | PDF ↗ |
| K933831 | PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC. | Nu-Dent, Inc. | 1993-12-06 | Traditional | PDF ↗ |
| K925062 | PERMAFLEX PERMANENT SOFT DENTURE RELINER | Protech Professional Products, Inc. | 1993-03-31 | Traditional | PDF ↗ |
| K926406 | DUAL CURE RELINE MATERIAL | Dentsply Intl. | 1993-03-31 | Traditional | PDF ↗ |
| K925275 | SOFT DENTURE RELINE MATERIAL ELASTOLINE | Great Lakes Orthodontics, Ltd. | 1993-01-11 | Traditional | PDF ↗ |
| K924422 | PALABOND | Heraeus Kulzer, Inc. | 1992-11-04 | Traditional | PDF ↗ |
| K915898 | PALADUR | Heraeus Kulzer, Inc. | 1992-09-16 | Traditional | PDF ↗ |
| K912990 | CONVERBASE | Wilde-USA, Inc. | 1992-03-25 | Traditional | PDF ↗ |
| K920557 | WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX | Wilde-USA, Inc. | 1992-03-20 | Traditional | PDF ↗ |
| K912993 | WILDE DENTURE RESINS | Wilde-USA, Inc. | 1992-02-03 | Traditional | PDF ↗ |
| K915377 | SR-IVOCAP PLUS | Ivoclar North America, Inc. | 1992-01-31 | Traditional | PDF ↗ |
| K912991 | WILDE AUXILIARIES | Wilde-USA, Inc. | 1991-12-19 | Traditional | PDF ↗ |
| K913655 | PROBASE HOT AND PROBASE COLD | Ivoclar North America, Inc. | 1991-10-17 | Traditional | PDF ↗ |
| K913698 | ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL | Heraeus Kulzer, Inc. | 1991-10-09 | Traditional | PDF ↗ |
| K913699 | MODERN MATERIALS ORTHODONTIC RESIN | Heraeus Kulzer, Inc. | 1991-10-09 | Traditional | PDF ↗ |
| K913040 | RIBBOND(TM) | Ribbond, Inc. | 1991-10-07 | Traditional | PDF ↗ |
| K910795 | COMFOR-DENT DENTURE LINER | Comfort Acrylics Co. | 1991-07-11 | Traditional | PDF ↗ |
| K910465 | MELIODENT, DENTURE RESIN | Heraeus Kulzer, Inc. | 1991-06-06 | Traditional | PDF ↗ |
| K905702 | NEW TRIAD TRANSHEET DENTURE BASE MATERIAL | Dentsply Intl. | 1991-04-29 | Traditional | PDF ↗ |
| K902972 | FLEXOR (DENTURE ACRYLIC RELINE MATERIAL) | Cmp Industries, LLC | 1990-10-04 | Traditional | PDF ↗ |
| K902115 | PALAPRESS(R) VARIO RESIN | Kulzer, Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K901621 | NEW PER-FIT(R) IMPROVED | Dental Product Co. | 1990-06-26 | Traditional | PDF ↗ |
| K901789 | PALADON(R) 65 | Kulzer, Inc. | 1990-06-22 | Traditional | PDF ↗ |
| K900799 | COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS | Comfort Acrylics Co. | 1990-05-15 | Traditional | PDF ↗ |
| K900301 | NOVUS BONDING AGENT | The Hygenic Corp. | 1990-05-15 | Traditional | PDF ↗ |
| K896980 | PALFIQUE LIGHT LINER | Tokuyama America, Inc. | 1990-05-15 | Traditional | PDF ↗ |
| K896981 | TOKUSO REBASE | Tokuyama America, Inc. | 1990-05-15 | Traditional | PDF ↗ |
| K896139 | SR-IVOSEAL | Ivoclar North America, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K896130 | SR-IVOCAP | Ivoclar North America, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K896719 | PRIMER-P ADHESIVE AGENT | Parkell | 1990-02-22 | Traditional | PDF ↗ |
| K895714 | ORTHO-KEV APPLIANCE REINFORCING SYSTEM | American Orthodontics | 1989-12-21 | Traditional | PDF ↗ |
| K895742 | LITELINE VLC SOFT RELINE | Dentsply Intl. | 1989-12-18 | Traditional | PDF ↗ |
| K895222 | CURAY-FORM | Scientific Pharmaceuticals, Inc. | 1989-10-24 | Traditional | PDF ↗ |
| K894564 | RELIANCE LIGHT CURE RETAINER ACRYLIC | Reliance Orthodontic Products, Inc. | 1989-10-17 | Traditional | PDF ↗ |
| K892452 | PALASEAL(R) | Kulzer, Inc. | 1989-06-16 | Traditional | PDF ↗ |
| K890830 | DENTURE RESIN | G-C Intl. Corp. | 1989-05-01 | Traditional | PDF ↗ |
| K884865 | PERMASEAL AND DENTURE SEAL | American Mfg., Inc. | 1989-01-30 | Traditional | PDF ↗ |
| K884751 | DANSU PERMANENT CHAIR SOFT LINER | American Mfg., Inc. | 1989-01-27 | Traditional | PDF ↗ |
| K883799 | BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN | Austenal Dental, Inc. | 1988-10-20 | Traditional | PDF ↗ |
| K882482 | TRIAD ORTHODONTIC GEL | Dentsply Intl. | 1988-08-12 | Traditional | PDF ↗ |
| K881245 | DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER | Cadco Dental Products, Inc. | 1988-07-21 | Traditional | PDF ↗ |
| K874025 | 2ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN | Astron Dental Corp. | 1987-12-23 | Traditional | PDF ↗ |
| K873738 | ACRYLIC BASE DENTURE MATERIALS | E&D Dental Manufacturing Co. | 1987-11-20 | Traditional | PDF ↗ |
| K871849 | LIGHT CURE DENTURE GLAZE | Austenal Dental, Inc. | 1987-08-10 | Traditional | PDF ↗ |
| K871497 | LINER OR GSRI-PNF | Gulf South Research Institute | 1987-06-17 | Traditional | PDF ↗ |
| K871038 | LUTEMOLL (BIOPLAST) | B. L. Dental Co. | 1987-05-19 | Traditional | PDF ↗ |
| K871312 | FIBREFLEX | Biomedical Composites, Ltd. | 1987-04-15 | Traditional | PDF ↗ |
| K870908 | STEADY RESIN | Great Lakes Orthodontics, Ltd. | 1987-03-19 | Traditional | PDF ↗ |
| K863630 | AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL | Austenal Dental, Inc. | 1987-03-11 | Traditional | PDF ↗ |
| K864708 | SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN | Ivoclar USA, Inc. | 1987-02-25 | Traditional | PDF ↗ |
| K870148 | DURA ORTHO ACRYLIC | Reliance Dental Mfg. Co. | 1987-02-19 | Traditional | PDF ↗ |
| K862557 | AUSTENAL ACUSOFT SOFT LINER | Austenal Dental, Inc. | 1987-02-19 | Traditional | PDF ↗ |
Product code EBI · Class II · Dental. Data: openFDA.