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 28, 2018 | K181476 | Prime&Bond active Universal Adhesive Dentsply Sirona | KLE |
| Sep 26, 2018 | K180803 | BeautiBond Universal Shofu Dental Corporation | KLE |
| Aug 29, 2018 | K180802 | Meta P&Bond Meta Biomed Co., Ltd., KR | KLE |
| Feb 6, 2018 | K172953 | Acid Etchant American Orthodontics | KLE |
| Jan 16, 2018 | K172977 | Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel Nanova Biomaterials, Inc. | KLE |
| Nov 28, 2017 | K171226 | TOKUYAMA UNIVERSAL BOND Tokuyama Dental Corporation, JP | KLE |
| Nov 21, 2017 | K172176 | Parkell Universal Adhesive Parkell, Inc. | KLE |
| Aug 31, 2017 | K172106 | SHOFU MZ Primer Plus Shofu Dental Corporation | KLE |
| Mar 17, 2017 | K161077 | RnD TE and RnD SE Apex Dental Materials, Inc. | KLE |
| Nov 21, 2016 | K161891 | HC Primer Shofu Dental Corporation | KLE |
| Oct 25, 2016 | K161042 | CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Kuraray Noritake Dental, Inc., JP | KLE |
| Sep 9, 2016 | K161051 | All-Bond Universal w/BAC (not finalized) Bisco, Inc. | KLE |
| Dec 9, 2015 | K152243 | One Coat 7 Universal Coltene/Whaledent AG, CH | KLE |
| Nov 20, 2015 | K152110 | e-1 etchants E Dental Products | KLE |
| Oct 30, 2015 | K151619 | Prime&Bond Elect Universal Dental Adhesive Dentsply International, Inc. | KLE |
| Sep 18, 2015 | K151518 | BRUSH&BOND PLUS Parkell, Inc. | KLE |
| Aug 13, 2015 | K150703 | CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial) Kuraray Noritake Dental, Inc., JP | KLE |
| Jul 7, 2015 | K150933 | iBond Universal & iBond Ceramic Primer Heraeus Kulzer, LLC, Mitsui Chemicals Group | KLE |
| Jun 23, 2015 | K150696 | Jade 37% Phosphoric Acid Etchant Gel Dharma Research, Inc. | KLE |
| Apr 20, 2015 | K143140 | G-Premio BOND GC America, Inc. | KLE |
| Apr 3, 2015 | K150164 | Monobond Etch & Prime Ivoclar Vivadent, AG, LI | KLE |
| Feb 24, 2015 | K142848 | EAZY PRIMER Parkell, Inc. | KLE |
| Nov 17, 2014 | K141839 | PREMIER ETCH Premier Dental Products Co. | KLE |
| Aug 20, 2014 | K140537 | TENURE4G Den-Mat Holdings, LLC | KLE |
| Aug 1, 2014 | K141610 | FUTURABOND M+ Voco GmbH, DE | KLE |
| Apr 11, 2014 | K131734 | ALL-BOND UNIVERSAL SC (NOT FINALIZED) Bisco, Inc. | KLE |
| Feb 11, 2014 | K133318 | ADHESE UNIVERSAL Ivoclar Vivadent, AG | KLE |
| Jan 3, 2014 | K132923 | FUSION SINGLE LINK Angelus Industria DE Productos Odontologicos SA | KLE |
| Dec 20, 2013 | K133078 | K-ETCHANT SYRINGE; NEEDLE TIP (E) Kuraray Noritake Dental, Inc., JP | KLE |
| Nov 1, 2013 | K132450 | CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND Kuraray Noritake Dental, Inc., JP | KLE |
| Sep 10, 2013 | K131043 | APEX UNIVERSAL ADHESIVE Apex Dental Materials, Inc. | KLE |
| Sep 6, 2013 | K131357 | PEAK Z Ultradent Products, Inc. | KLE |
| Aug 30, 2013 | K131430 | CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL Kuraray Noritake Dental, Inc., JP | KLE |
| Aug 27, 2013 | K131049 | ZRP Apex Dental Materials, Inc. | KLE |
| Aug 26, 2013 | K131212 | PREMIER CERAMIC PRIMER Premier Dental Products Co. | KLE |
| Aug 22, 2013 | K131432 | CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL Kuraray Noritake Dental, Inc., JP | KLE |
| Jul 11, 2013 | K131248 | ETCH GEL Dmg America, LLC | KLE |
| Jun 20, 2013 | K130486 | FUTURABOND UNIVERSAL Voco GmbH, DE | KLE |
| Mar 19, 2013 | K122522 | DENTOETCH QUICKBOND BOND ACTIVATOR Itena Clinical, CA | KLE |
| Dec 7, 2012 | K123278 | IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF Heraeus Kulzer, LLC | KLE |
| Nov 28, 2012 | K123119 | CERARESIN BOND Shofu Dental Corporation | KLE |
| May 31, 2012 | K120620 | CLEAN AND BOOST Apex Dental Materials, Inc. | KLE |
| May 24, 2012 | K120767 | ES BOND Spident Co., Ltd., KR | KLE |
| Mar 30, 2012 | K120213 | ETCH-RITE SUPREME Pulpdent Corporation | KLE |
| Dec 7, 2011 | K112597 | SEITY 37% PHOSPHORIC ACID ETCHANT GEL Mycone Dental Supply Co., Inc. | KLE |
| Nov 17, 2011 | K112118 | DREAMBOND Bisco, Inc. | KLE |
| Oct 14, 2011 | K111980 | CLEARFIL TRI-S BOND PLUS Kuraray America, Inc. | KLE |
| Oct 14, 2011 | K111975 | CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK Kuraray Medical, Inc., JP | KLE |
| Sep 21, 2011 | K111876 | Z BOND, PRELUDE ONE Danville Materials, Inc. | KLE |
| Sep 8, 2011 | K110403 | PROLINK ADHESIVES (PROLINK, PROLINK SE) Silmet , Ltd., IL | KLE |
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