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 |
|---|---|---|---|
| Sep 22, 1995 | K953476 | MULTI-PRIME AKA/MONO-PRIME Silicon-Und Composite Spezialitaten GmbH, DE | KLE |
| Sep 7, 1995 | K953859 | BOND-IT DUAL CURE ACTIVATOR Jeneric/Pentron, Inc. | KLE |
| Sep 7, 1995 | K953592 | REVOLUTION BOND E&D Dental Products, Inc. | KLE |
| Aug 29, 1995 | K953527 | PERMUALUTE INDIRECT RESTORATIVE BONDING PRIMERS Ultradent Products, Inc. | KLE |
| Jun 20, 1995 | K952124 | ABOND Parkell, Inc. | KLE |
| Jun 20, 1995 | K952123 | MS EMULSION Parkell, Inc. | KLE |
| May 23, 1995 | K951867 | PERMAQUIK BONDING PRIMER Ultradent Products, Inc. | KLE |
| May 23, 1995 | K951864 | PRIME & BOND DIRECT COMPOSITE BONDING AGENT Dentsply Intl. | KLE |
| May 12, 1995 | K951583 | PERMAQUIK BONDING PRIMER Ultradent Products, Inc. | KLE |
| May 12, 1995 | K951220 | HEMA-GLU Health-Dent Intl., Inc. | KLE |
| Apr 10, 1995 | K950905 | C&B-METABOND RADIOPAQUE POWDER Parkell, Inc. | KLE |
| Mar 23, 1995 | K950860 | PERMALUTE Ultradent Products, Inc. | KLE |
| Jan 3, 1995 | K945604 | ECLIPTOMER Bisco, Inc. | KLE |
| Dec 14, 1994 | K945112 | PULPDENT DUAL CURE UNFILLED BONDING RESIN Pulpdent Corp. | KLE |
| Nov 22, 1994 | K933360 | GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER Miles Inc., Dental Products | KLE |
| Sep 9, 1994 | K943738 | OPTIBOND-D Sybron Dental Specialties, Inc. | KLE |
| Aug 23, 1994 | K943373 | PERMAGEN F/DC Ultradent Products, Inc. | KLE |
| Aug 10, 1994 | K943170 | CLEARFIL LINER BOND 2 Kuraray Company, Ltd. | KLE |
| Aug 10, 1994 | K943167 | CLEARFIL NEW BOND Kuraray Company, Ltd. | KLE |
| Aug 10, 1994 | K943166 | CLEARFIL LINER BOND SYSTEM Kuraray Company, Ltd. | KLE |
| Aug 10, 1994 | K943165 | CLEARFIL PHOTO BOND Kuraray Company, Ltd. | KLE |
| Jul 6, 1994 | K942017 | V-PRIMER Parkell, Inc. | KLE |
| Jul 5, 1994 | K942493 | SCOTCHBOND MULTI-PURPOSE PLUS DENTAL ADHESIVE SYSTEM 3M Company | KLE |
| Jun 10, 1994 | K941572 | FLUORIDE-PSA PRIME/ADHESIVE Dentsply Intl. | KLE |
| Apr 15, 1994 | K940513 | OPTIBOND Kerr Corporation (Danbury) | KLE |
| Mar 15, 1994 | K936222 | DENTIN CONDITIONING AND ADHESIVE SYSTEM Jeneric/Pentron, Inc. | KLE |
| Mar 10, 1994 | K935961 | GC FUJI COAT LC GC America, Inc. | KLE |
| Mar 7, 1994 | K935735 | ATTACHMENT BOND Heraeus Kulzer, Inc. | KLE |
| Feb 3, 1994 | K936100 | CLEARFIL LINER BOND 2 Kuraray Intl. Corp. | KLE |
| Jan 26, 1994 | K934596 | BISCO DUO LINK D/C LUTING COMPOSITE Bisco, Inc. | KLE |
| Dec 30, 1993 | K934690 | KERR OPTIBOND, MODIFICATION Kerr Corporation (Danbury) | KLE |
| Aug 24, 1993 | K931710 | PULPDENT DENTAL BOND ENHANCER 2-B Pulpdent Corp. | KLE |
| Jul 22, 1993 | K932379 | ALL-BOND(R) JR. Bisco, Inc. | KLE |
| Jul 22, 1993 | K931870 | BONDING RESIN PRODUCT LINE Ultradent Products, Inc. | KLE |
| Jul 8, 1993 | K931838 | DENTHESIVE II Heraeus Kulzer, Inc. | KLE |
| Jul 8, 1993 | K931812 | NEW DENTINE ADHESIVE Dentsply Intl. | KLE |
| May 27, 1993 | K930504 | NEW DENTIN PRIMER Dentsply Intl. | KLE |
| Apr 20, 1993 | K930989 | PULPDENT UNFILLED DUAL CURE BONDING RESIN Pulpdent Corp. | KLE |
| Mar 31, 1993 | K924378 | RESTOBOND 4 Lee Pharmaceuticals | KLE |
| Feb 26, 1993 | K913581 | WILDE ADHESIVE BONDING SYSTEM Wilde-USA, Inc. | KLE |
| Jan 11, 1993 | K925404 | CLEARFIL PORCELAIN BOND ACTIVATOR Kuraray Co. | KLE |
| Nov 23, 1992 | K924670 | DENTIN RELIEF Professional Technologies Corp. | KLE |
| Oct 16, 1992 | K924181 | POLIBOND Voco GmbH | KLE |
| Sep 29, 1992 | K923842 | BISCO UNIVERSAL BOND-3 Bisco, Inc. | KLE |
| Sep 29, 1992 | K923546 | OPTIBOND Kerr Corporation (Danbury) | KLE |
| Aug 3, 1992 | K922615 | COLTENE A.R.T. BOND Coltene/Whaledent, Inc. | KLE |
| Jun 9, 1992 | K921701 | DURAFILL BOND Heraeus Kulzer, Inc. | KLE |
| Mar 20, 1992 | K920424 | SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM 3M Company | KLE |
| Mar 6, 1992 | K915511 | MIRAGE COMPLETE KIT AND MIRAGE ABC KIT Mirage Dental Systems | KLE |
| Mar 2, 1992 | K915830 | PRISMA UNIVERSAL BOND(R) 3 Dentsply Intl. | KLE |
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