Agent, Tooth Bonding, Resin
Regulation 872.3200
9510(k)s in 12 months (421 all time)
0recalls in 12 months (20 all time)
20recalls that name a 510(k)
Top companies in KLE
| Company | 510(k)s | Recalls |
|---|---|---|
| Ultradent Products, Inc. | 19 | 2 |
| Dentsply Intl. | 20 | 0 |
| Heraeus Kulzer, Inc. | 19 | 0 |
| Bisco, Inc. | 18 | 0 |
| Parkell | 16 | 0 |
| Kerr Corporation | 4 | 10 |
| Kuraray Medical, Inc. | 14 | 0 |
| Shofu Dental Corp. | 13 | 0 |
| GC America, Inc. | 11 | 0 |
| Pulpdent Corp. | 11 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 16, 2005 | K052699 | VERSA-LINK PORCELAIN BONDING SYSTEM Sultan Chemists, Inc. | KLE |
| Oct 21, 2005 | K052501 | MULTIPLE RESIN TOOTH BONDING AGENT Cosmedent, Inc. | KLE |
| Oct 17, 2005 | K052189 | REVENEER CERAMIC REPAIR SYSTEM Schutz-Dental GmbH, DE | KLE |
| Aug 9, 2005 | K051796 | CLEARFIL TRI-S BOND SINGLE DOSE Kuraray Medical Kurashiki Plant | KLE |
| Jul 15, 2005 | K051707 | ECLIPSE BONDING AGENT Dentsply Intl. | KLE |
| Jul 12, 2005 | K051463 | XENO ADHESIVE WITH ACTIVATOR Dentsply Intl. | KLE |
| Jun 29, 2005 | K051050 | SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092 Schutz-Dental GmbH, DE | KLE |
| Jun 7, 2005 | K051006 | IBOND NEXT GENERATION Heraeus Kulzer,GmbH | KLE |
| Apr 20, 2005 | K050647 | ALL-IN-ONE Bisco, Inc. | KLE |
| Mar 24, 2005 | K050331 | ADHESIVE 1 Southern Dental Industries, Inc. | KLE |
| Feb 25, 2005 | K043170 | BOSWORTH BOND Harry J. Bosworth Co. | KLE |
| Feb 23, 2005 | K050386 | PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM Dentsply International | KLE |
| Jan 10, 2005 | K043043 | HERMES BOND 2 3M Espe AG Dental Products, DE | KLE |
| Jan 3, 2005 | K043562 | BC PLUS Vericom Co., Ltd., KR | KLE |
| Nov 26, 2004 | K042913 | CLEARFIL TRI-S BOND Kuraray Medical, Inc. | KLE |
| Nov 24, 2004 | K042806 | QUADRANT UNIT-1-BOND Cavex Holland BV, NL | KLE |
| Nov 22, 2004 | K042614 | S&C-SELF ETCH PR-BOND S & C Polymer GmbH, DE | KLE |
| Nov 10, 2004 | K041680 | ORAJEL ADVANCED TOOTH DESENSITIZER Del Pharmaceuticals, Inc. | KLE |
| Nov 1, 2004 | K042670 | FUTURABOND NR Voco GmbH | KLE |
| Sep 9, 2004 | K040079 | M.L. PRIMER Shofu Dental Corp. | KLE |
| Aug 30, 2004 | K041960 | COMPOSITE/COMPOMER REPAIR KIT Dmg USA, Inc. | KLE |
| Jun 29, 2004 | K041471 | G-BOND GC America, Inc. | KLE |
| Jun 29, 2004 | K040952 | PRELUDE Danville Materials, Inc. | KLE |
| Jun 16, 2004 | K041343 | XENO NM LIGHT CURED DENTAL ADHESIVE Dentsply International | KLE |
| May 10, 2004 | K040857 | MODIFICATION TO ADPER PROMPT 3M Espe AG Dental Products, DE | KLE |
| Feb 6, 2004 | K033974 | HERMES BOND 3M Espe AG Dental Products, DE | KLE |
| Jan 29, 2004 | K033938 | CLEARFIL PROTECT BOND Kuraray Medical, Inc. | KLE |
| Jan 23, 2004 | K033760 | ONE COAT SE BOND Coltene/Whaledent, Inc. | KLE |
| Dec 10, 2003 | K032953 | EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT Pulpdent Corporation | KLE |
| Dec 3, 2003 | K032626 | PERMAQUICK SE BONDING SYSTEM Ultradent Products, Inc. | KLE |
| Sep 9, 2003 | K032179 | COMP. E Parkell, Inc. | KLE |
| Aug 5, 2003 | K031915 | PULPDENT ETCH-RITE ROYALE Pulpdent Corporation | KLE |
| Jul 2, 2003 | K031444 | OPTIBOND FL Kerr Dental Materials Center | KLE |
| Jun 13, 2003 | K030844 | FINAL VARNISH LC Voco GmbH | KLE |
| May 9, 2003 | K030743 | ETCHANT 40% Confi-Dental Products Co. | KLE |
| Mar 26, 2003 | K024356 | CLEARFIL SILANE KIT Kuraray Medical, Inc. | KLE |
| Feb 11, 2003 | K023842 | CLEARFIL SE BOND PLUS Kuraray Medical, Inc. | KLE |
| Jan 23, 2003 | K023776 | XENO III DENTAL ADHESIVE Dentsply Intl. | KLE |
| Nov 22, 2002 | K022973 | ADHESIVE 14 Ab Ardent | KLE |
| Oct 28, 2002 | K023042 | PQ1 Ultradent Products, Inc. | KLE |
| Oct 28, 2002 | K022612 | IBOND GLUMA INSIDE Heraeus Kulzer, Inc. | KLE |
| Jun 7, 2002 | K021427 | CLEARFIL SA PRIMER Kuraray Medical, Inc. | KLE |
| May 16, 2002 | K020514 | PULPDENT GLAZE II Pulpdent Corporation | KLE |
| Apr 24, 2002 | K020570 | SIMPLICITY Apex Dental Materials, Inc. | KLE |
| Apr 22, 2002 | K020499 | BOND-3 ADHESIVE Jeneric/Pentron, Inc. | KLE |
| Apr 19, 2002 | K020303 | XR PRIMER 2 Kerr Dental Materials Center | KLE |
| Apr 4, 2002 | K020946 | ADPER PROMPT 3M Espe AG Dental Products, DE | KLE |
| Mar 20, 2002 | K020239 | TOUCH&BOND-PLUS Parkell, Inc. | KLE |
| Feb 22, 2002 | K014027 | OPTIBOND SOLO PLUS 4 Kerr Dental Materials Center | KLE |
| Feb 22, 2002 | K013543 | BOND-1 C & B Jeneric/Pentron, Inc. | KLE |
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