Resin, Denture, Relining, Repairing, Rebasing
Regulation 872.3760
10510(k)s in 12 months (335 all time)
0recalls in 12 months (16 all time)
10recalls that name a 510(k)
Top companies in EBI
| Company | 510(k)s | Recalls |
|---|---|---|
| Dentsply Intl. | 16 | 0 |
| Heraeus Kulzer, Inc. | 13 | 0 |
| GC America, Inc. | 12 | 0 |
| Cmp Industries, LLC | 5 | 6 |
| Harry J. Bosworth Co. | 8 | 0 |
| Lang Dental Mfg. Co., Inc. | 7 | 1 |
| Voco GmbH | 8 | 0 |
| Vertex-Dental B.V. | 7 | 0 |
| Dentsply Sirona | 6 | 0 |
| Stick Tech , Ltd. | 6 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 24, 1999 | K984467 | FUSICRYL Micro Dental Laboratories | EBI |
| Feb 18, 1999 | K984483 | A-SOFT RELINER S & C Polymer GmbH, DE | EBI |
| Feb 9, 1999 | K981862 | RESIN 4 Harry J. Bosworth Co. | EBI |
| Jan 8, 1999 | K984341 | STERNVANTAGE VARNISH LC, MODEL 221001 Sterngold/Implamed | EBI |
| Jan 7, 1999 | K983547 | PROTECH PLUS Protech, Inc. | EBI |
| Dec 16, 1998 | K983876 | MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind | EBI |
| Nov 13, 1998 | K983357 | MUCOPREN SOFT RELINING SYSTEM Roydent Dental Products, Inc. | EBI |
| Nov 3, 1998 | K981691 | SILICONE SOFT RELINE Harry J. Bosworth Co. | EBI |
| Oct 19, 1998 | K982695 | GC RELINE GC America, Inc. | EBI |
| Oct 1, 1998 | K981861 | LINER 1:HARD RELINE LIQUID Harry J. Bosworth Co. | EBI |
| Aug 24, 1998 | K982537 | TOKUYAMA SOFRELINER Tokuyama America, Inc. | EBI |
| Jun 16, 1998 | K981448 | KERR HARD DENTURE RELINE MATERIAL Sybron Dental Specialties, Inc. | EBI |
| Apr 30, 1998 | K980616 | PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15) Kohler Medizintechnik GmbH & Co. KG, DE | EBI |
| Mar 16, 1998 | K974865 | CSR Parkell, Inc. | EBI |
| Mar 11, 1998 | K974160 | BRUXTRAK MATERIAL Bruxcare, LLC | EBI |
| Feb 24, 1998 | K974727 | JET ACRYLIC LIQUID-MONOMER, ORTHO JET POWDER-POLYMER, PLASTICIZED METHACRYLATE HOMOPOLYMER, METHACRYLATE COPOLYMER, METR J.B.C and Co. | EBI |
| Feb 10, 1998 | K974772 | UFI GEL C Voco GmbH | EBI |
| Feb 10, 1998 | K973542 | MASKY Pressing DI Monticelli Rag. Stefano | EBI |
| Nov 13, 1997 | K972553 | LANG DENTAL RESIN A97 FIBRED PINK Lang Dental Mfg. Co., Inc. | EBI |
| Sep 16, 1997 | K972573 | LIQCRYLIC PRO DENTAL RESIN Dentsply Intl. | EBI |
| Jul 21, 1997 | K971138 | DINABASE (TM) Sultan Chemists, Inc. | EBI |
| May 14, 1997 | K970522 | MYERSON'S ECONOMY DENTURE BASE MATERIAL Austenal, Inc. | EBI |
| Dec 6, 1996 | K964040 | TRUBYTE SOFT RELINE SYSTEM Dentsply Intl. | EBI |
| Dec 4, 1996 | K963736 | SOFT DENTURE REBASING RESIN Sybron Dental Specialties, Inc. | EBI |
| Oct 29, 1996 | K963144 | GC BASELINE GC America, Inc. | EBI |
| Aug 7, 1996 | K962333 | V.R.S. DENTURE RESIN MATERIAL Vident | EBI |
| Jul 22, 1996 | K962374 | FIBER-SPLINT ML MULTILAYER Polydentia USA | EBI |
| Jun 26, 1996 | K961995 | QUICKSPLINT Heraeus Kulzer, Inc. | EBI |
| May 17, 1996 | K961200 | BOSWORTH LIQUID RESIN II Harry J. Bosworth Co. | EBI |
| Jan 18, 1996 | K953589 | TOKUYAMA SOFT RELINING Tokuyama America, Inc. | EBI |
| Dec 28, 1995 | K954637 | AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER American Dental Products, Inc. | EBI |
| Nov 29, 1995 | K954810 | MYERSON IR DENTURE BASE Austenal, Inc. | EBI |
| Oct 30, 1995 | K954689 | CONNECT Sybron Dental Specialties, Inc. | EBI |
| Oct 2, 1995 | K953743 | PALASPLINT Heraeus Kulzer, Inc. | EBI |
| Sep 27, 1995 | K953381 | PROP. CONQUEST C&B VLC GLAZE/SEALANT Jeneric/Pentron, Inc. | EBI |
| Aug 28, 1995 | K953119 | BOSWORTH RESIN II Bosworth Co. | EBI |
| Jul 7, 1995 | K952351 | PRECISE DENTURE BASE RESIN Dentsply Intl. | EBI |
| Mar 2, 1995 | K944466 | SEALDENT Scientific Pharmaceuticals, Inc. | EBI |
| Feb 27, 1995 | K943905 | PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER Professional Positioners, Inc. | EBI |
| Feb 16, 1995 | K946317 | HARRY J. BOSWORTH RESIN I. Harry J. Bosworth Co. | EBI |
| Feb 2, 1995 | K945711 | EXCEL-P FORMULA AUTO-CURE DENTURE BASE St. George Technology, Inc. | EBI |
| Dec 20, 1994 | K942562 | PROSTHOFLEX Knopf Assoc, Inc. | EBI |
| May 27, 1994 | K941925 | ORTHO-JET ACRYLIC RESIN - SPARKLE Lang Dental Mfg. Co., Inc. | EBI |
| May 4, 1994 | K940565 | COE-SOFT LC GC America, Inc. | EBI |
| Jan 26, 1994 | K935261 | KOOLINER II GC America, Inc. | EBI |
| Jan 21, 1994 | K930939 | REBARON LC GC America, Inc. | EBI |
| Jan 18, 1994 | K934019 | EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO St. George Technology, Inc. | EBI |
| Jan 5, 1994 | K933468 | MYERSON'S PERMASOFT SOFT RELINE MATERIAL Austenal, Inc. | EBI |
| Dec 8, 1993 | K934248 | ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER Wallace A. Erickson & Co. | EBI |
| Dec 6, 1993 | K933831 | PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC. Nu-Dent, Inc. | EBI |
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