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 |
|---|---|---|---|
| Jan 5, 2005 | K043295 | VERSYO.DIRECT Heraeus Kulzer, Inc. | EBI |
| Dec 8, 2004 | K042931 | TUF LINK SILICONE RELINER Dentatus USA , Ltd. | EBI |
| May 25, 2004 | K040881 | METACRYL Great Lakes Orthodontics, Ltd. | EBI |
| Mar 19, 2004 | K034024 | TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS Bisco, Inc. | EBI |
| Jan 21, 2004 | K033632 | VARIFLEX Great Lakes Orthodontics, Ltd. | EBI |
| Jan 15, 2004 | K033472 | TESCERA U-BAR AND BARRELS Bisco, Inc. | EBI |
| Dec 22, 2003 | K033629 | VERSYO.BOND Heraeus Kulzer, Inc. | EBI |
| Dec 19, 2003 | K033020 | IMPAK ACRYLIC REPAIR RESIN LIQUID Cmp Industries, LLC | EBI |
| Sep 26, 2003 | K032892 | MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM Dentsply Intl. | EBI |
| Sep 23, 2003 | K032773 | DIAMOND D HIGH IMPACT DENTURE ACRYLIC Mycone Dental Supply Co., Inc. | EBI |
| Jul 3, 2003 | K031070 | CARBON FIBER BRIDGE, MODEL 28757 Nobel Biocare AB | EBI |
| Jun 19, 2003 | K030916 | UFI GEL HARD C Voco GmbH, DE | EBI |
| May 29, 2003 | K030663 | TOKUYAMA SOFRELINER TOUGH Tokuyama Dental Corporation | EBI |
| Apr 10, 2003 | K030072 | EVERSTICK PERIO Stick Tech , Ltd. | EBI |
| Oct 2, 2002 | K022641 | TOKUYAMA REBASE II Tokuyama America, Inc. | EBI |
| Jul 19, 2002 | K021437 | SECURE SOFT Imtec Corp. | EBI |
| Jun 14, 2002 | K021586 | SECURE RELINE/PICKUP MATERIAL Imtec Corp. | EBI |
| May 28, 2002 | K021121 | AROMACRYL Aromacryl, LLC | EBI |
| May 13, 2002 | K021126 | EVERSTICK ORTHO Stick Tech , Ltd. | EBI |
| Jan 25, 2002 | K013881 | RIBBOND - TRIAXIAL Ribbond, Inc. | EBI |
| Nov 14, 2001 | K012882 | BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060 Thermoelastic Technologies, Inc. | EBI |
| Nov 5, 2001 | K011799 | EVERSTICKNET Stick Tech , Ltd. | EBI |
| Nov 5, 2001 | K011788 | EVERSTICK Stick Tech , Ltd. | EBI |
| Sep 5, 2001 | K011820 | DENTORIUM CONVERTIBLE ACRYLIC Nats Corp. | EBI |
| Aug 23, 2001 | K011762 | HI-WAVE; POUR-PLUS Denplus, Inc., CA | EBI |
| Jul 12, 2001 | K011560 | TRUBYTE DENTURE BASE RESIN SYSTEM Dentsply Intl. | EBI |
| Jun 26, 2001 | K011277 | HARD RELINER S & C Polymer GmbH, DE | EBI |
| May 31, 2001 | K010800 | VERSYO.COM Heraeus Kulzer, Inc. | EBI |
| Jan 8, 2001 | K003334 | STICK NET Stick Tech , Ltd. | EBI |
| Jan 4, 2001 | K003333 | STICK Stick Tech , Ltd. | EBI |
| Aug 30, 2000 | K002048 | JBC OPAQUE AND GLITTER J.B.C and Co. | EBI |
| Jun 23, 2000 | K001640 | BIOSOFT RESIN Biosoft International Corp. | EBI |
| Jun 16, 2000 | K001463 | SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156 Davis Schottlander & Davis, Ltd. | EBI |
| Feb 10, 2000 | K992176 | EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL St. George Technology, Inc. | EBI |
| Jan 20, 2000 | K993827 | UFI GEL HARD Voco GmbH, CA | EBI |
| Dec 22, 1999 | K993717 | ENIGMA HI-BASE DENTURE BASE MATERIAL Davis Schottlander & Davis, Ltd. | EBI |
| Oct 7, 1999 | K991687 | MODIFICATION TO LINER II: SOFT RELINE LIQUID Bosworth Co. | EBI |
| Oct 6, 1999 | K992956 | LUCITONE FRS FLEXIBEL DENTAL RESIN Dentsply Intl. | EBI |
| Sep 22, 1999 | K992609 | HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 Kay See Dental Mfg. Co. | EBI |
| Sep 22, 1999 | K991577 | NIC TONE ACRYLIC RESINS Manufacturera Dental Continental | EBI |
| Sep 8, 1999 | K991996 | IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR Denplus, Inc., CA | EBI |
| Jul 9, 1999 | K991774 | ACRON MC MODIFICATION GC America, Inc. | EBI |
| May 28, 1999 | K990736 | GC RELINE SOFT/EXTRA SOFT GC America, Inc. | EBI |
| May 25, 1999 | K990763 | VITRON M Espe Dental AG, DE | EBI |
| May 20, 1999 | K991220 | VITRON H Espe Dental AG, DE | EBI |
| May 17, 1999 | K990699 | ORTHO-GLOW GLITTER Harry J. Bosworth Co. | EBI |
| Apr 13, 1999 | K983461 | UNI-FLEX RESIN Trans-Atlantic Dental | EBI |
| Mar 25, 1999 | K990056 | JELDENT MULTICRYL J.F. Jelenko & Co., Inc. | EBI |
| Mar 23, 1999 | K990448 | THE.R.MO.FREE Dentamax, Inc. | EBI |
| Feb 25, 1999 | K984365 | GC UNIFAST TRAD GC America, Inc. | EBI |
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