FDA Product Code
FDA Product Code KLE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3200
510(k) Clearances — 420 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262252 | MPa Max adhesive | Den-Mat Holdings, LLC | 2026-09-24 | Traditional | PDF ↗ |
| K260485 | Any-Etch | Mediclus Co., Ltd. | 2026-05-14 | Traditional | PDF ↗ |
| K260430 | Porcelain Etch Gel | Belport Company, Inc., Gingi-Pak | 2026-04-10 | Traditional | PDF ↗ |
| K252450 | Adhese 2 | Ivoclar Vivadent, Inc. | 2026-03-05 | Traditional | PDF ↗ |
| K260682 | Bond-PR Universal Adhesive | Premier Dental Products Company | 2026-03-03 | Traditional | PDF ↗ |
| K251587 | VITA VMLC Primer | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 2026-02-23 | Traditional | PDF ↗ |
| K252151 | els unibond | Saremco Dental AG | 2025-12-05 | Traditional | PDF ↗ |
| K252469 | MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA | Dmp Dental Industry S.A. | 2025-11-06 | Traditional | PDF ↗ |
| K251124 | G-Bond Universal | GC America, Inc. | 2025-10-02 | Traditional | PDF ↗ |
| K242530 | HF-Etchant Hydrofluoric Acid Etching Gel | Rizhao Huge Biomaterials Company, Ltd. | 2024-12-20 | Traditional | PDF ↗ |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling Agent | Rizhao Huge Biomaterials Company, Ltd. | 2024-11-08 | Traditional | PDF ↗ |
| K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) | Spident Co., Ltd. | 2024-11-01 | Traditional | PDF ↗ |
| K240153 | Ceramic Etchant (HF-5 and HF-9) | Liaoning Upcera Co., Ltd. | 2024-10-02 | Traditional | PDF ↗ |
| K241445 | K-Bond Universal | Spident Co., Ltd. | 2024-07-22 | Traditional | PDF ↗ |
| K241056 | Light Cure Adhesive | Sincera Technology (Changchun) Co., Ltd. | 2024-07-16 | Traditional | PDF ↗ |
| K240743 | Peak Universal Bond | Ultradent Products, Inc. | 2024-03-20 | Special | PDF ↗ |
| K231039 | CLEARFIL Universal Bond Quick 2 | Kuraray Noritake Dental, Inc. | 2023-12-13 | Traditional | PDF ↗ |
| K232978 | DX. Bond V Dental Bonding Adhesive | Sino-Dentex Co., Ltd. | 2023-09-22 | Traditional | PDF ↗ |
| K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal | Prevest Denpro Limited | 2023-08-11 | Traditional | PDF ↗ |
| K230465 | Hi-Bond Universal | Mediclus Co., Ltd. | 2023-05-22 | Traditional | PDF ↗ |
| K230009 | EZ Bond Universal | Meta Biomed Co., Ltd. | 2023-03-03 | Traditional | PDF ↗ |
| K222830 | Rainbow 360 | Kerr Corporation | 2023-01-12 | Traditional | PDF ↗ |
| K221450 | Phosphoric Acid Etching Gel | Rizhao Huge Biomaterials Company, Ltd. | 2022-09-12 | Traditional | PDF ↗ |
| K222357 | DenMat Glutaraldehyde Desensitizer | Denmat Holding, LLC | 2022-08-09 | Traditional | PDF ↗ |
| K221033 | UniPrime A, UniPrime E, UniPrime E/C | S&C Polymer Silicon- Und Composite Spezialitäten GmbH | 2022-07-06 | Traditional | PDF ↗ |
| K220804 | Dia-X Bond Universal | DiaDent Group International | 2022-06-15 | Special | PDF ↗ |
| K210804 | Adhese Universal DC, Cention Primer | Ivoclar Vivadent, AG | 2022-06-07 | Traditional | PDF ↗ |
| K213965 | BeautiBond Xtreme | Shofu Dental Corporation | 2022-03-18 | Traditional | PDF ↗ |
| K213401 | DIAPLUS Universal | DiaDent Group International | 2022-01-31 | Traditional | PDF ↗ |
| K213093 | STEP-1 PumEtch | Rounding Third, LLC | 2022-01-28 | Traditional | PDF ↗ |
| K210186 | PacBond One | Pac-Dent, Inc. | 2021-07-16 | Traditional | PDF ↗ |
| K210945 | Ultra SEP | Reliance Orthodontic Products, Inc. | 2021-07-08 | Traditional | PDF ↗ |
| K203760 | Tokuyama Universal Bond II | Tokuyama Dental Corporation | 2021-05-25 | Traditional | PDF ↗ |
| K192913 | R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2021-01-19 | Traditional | PDF ↗ |
| K200153 | Bright Bond Universal | Genoss Co., Ltd. | 2020-10-28 | Traditional | PDF ↗ |
| K200682 | BZF-29 | GC America, Inc. | 2020-10-02 | Traditional | PDF ↗ |
| K201787 | Light Cure Dental Adhesive | Rizhao Huge Biomaterials Company, Ltd. | 2020-09-25 | Traditional | PDF ↗ |
| K200462 | EtchPro Etching Gel | Belport Company, Inc., Gingi-Pak | 2020-09-02 | Traditional | PDF ↗ |
| K192392 | DiaPlus | DiaDent Group International | 2020-05-26 | Traditional | PDF ↗ |
| K192273 | DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit | DiaDent Group International | 2020-02-07 | Traditional | PDF ↗ |
| K183424 | Ambar, Ambar APS, Ambar Universal APS | Dentscare Ltda | 2019-12-13 | Traditional | PDF ↗ |
| K191656 | Zipbond | Sdi Limited | 2019-12-02 | Traditional | PDF ↗ |
| K192961 | ADH19 | 3M Deutschland GmbH | 2019-10-31 | Traditional | PDF ↗ |
| K191523 | Visalys Restorative Primer | Kettenbach GmbH & Co. KG | 2019-10-09 | Traditional | PDF ↗ |
| K191524 | Visalys Tooth Primer | Kettenbach GmbH & Co. KG | 2019-09-29 | Traditional | PDF ↗ |
| K183391 | Novidia Universal Bond | Nobio , Ltd. | 2019-09-24 | Traditional | PDF ↗ |
| K180917 | GC Acrylic Primer | GC America, Inc. | 2018-11-20 | Traditional | PDF ↗ |
| K182162 | OptiBond eXTRa Universal | Kerr Corporation | 2018-11-07 | Traditional | PDF ↗ |
| K181910 | BracePaste MTP Light Cure Primer | American Orthodontics | 2018-10-15 | Traditional | PDF ↗ |
| K181476 | Prime&Bond active Universal Adhesive | Dentsply Sirona | 2018-09-28 | Traditional | PDF ↗ |
| K180803 | BeautiBond Universal | Shofu Dental Corporation | 2018-09-26 | Traditional | PDF ↗ |
| K180802 | Meta P&Bond | Meta Biomed Co., Ltd. | 2018-08-29 | Traditional | PDF ↗ |
| K172953 | Acid Etchant | American Orthodontics | 2018-02-06 | Traditional | PDF ↗ |
| K172977 | Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel | Nanova Biomaterials, Inc. | 2018-01-16 | Traditional | PDF ↗ |
| K171226 | TOKUYAMA UNIVERSAL BOND | Tokuyama Dental Corporation | 2017-11-28 | Traditional | PDF ↗ |
| K172176 | Parkell Universal Adhesive | Parkell, Inc. | 2017-11-21 | Traditional | PDF ↗ |
| K172106 | SHOFU MZ Primer Plus | Shofu Dental Corporation | 2017-08-31 | Traditional | PDF ↗ |
| K161077 | RnD TE and RnD SE | Apex Dental Materials, Inc. | 2017-03-17 | Traditional | PDF ↗ |
| K161891 | HC Primer | Shofu Dental Corporation | 2016-11-21 | Traditional | PDF ↗ |
| K161042 | CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack | Kuraray Noritake Dental, Inc. | 2016-10-25 | Traditional | PDF ↗ |
| K161051 | All-Bond Universal w/BAC (not finalized) | Bisco, Inc. | 2016-09-09 | Traditional | PDF ↗ |
| K152243 | One Coat 7 Universal | Coltene/Whaledent AG | 2015-12-09 | Traditional | PDF ↗ |
| K152110 | e-1 etchants | E Dental Products | 2015-11-20 | Traditional | PDF ↗ |
| K151619 | Prime&Bond Elect Universal Dental Adhesive | Dentsply International, Inc. | 2015-10-30 | Traditional | PDF ↗ |
| K151518 | BRUSH&BOND PLUS | Parkell, Inc. | 2015-09-18 | Traditional | PDF ↗ |
| K150703 | CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial) | Kuraray Noritake Dental, Inc. | 2015-08-13 | Traditional | PDF ↗ |
| K150933 | iBond Universal & iBond Ceramic Primer | Heraeus Kulzer, LLC, Mitsui Chemicals Group | 2015-07-07 | Traditional | PDF ↗ |
| K150696 | Jade 37% Phosphoric Acid Etchant Gel | Dharma Research, Inc. | 2015-06-23 | Traditional | PDF ↗ |
| K143140 | G-Premio BOND | GC America, Inc. | 2015-04-20 | Traditional | PDF ↗ |
| K150164 | Monobond Etch & Prime | Ivoclar Vivadent, AG | 2015-04-03 | Traditional | PDF ↗ |
| K142848 | EAZY PRIMER | Parkell, Inc. | 2015-02-24 | Traditional | PDF ↗ |
| K141839 | PREMIER ETCH | Premier Dental Products Co. | 2014-11-17 | Traditional | PDF ↗ |
| K140537 | TENURE4G | Den-Mat Holdings, LLC | 2014-08-20 | Traditional | PDF ↗ |
| K141610 | FUTURABOND M+ | Voco GmbH | 2014-08-01 | Special | PDF ↗ |
| K131734 | ALL-BOND UNIVERSAL SC (NOT FINALIZED) | Bisco, Inc. | 2014-04-11 | Traditional | PDF ↗ |
| K133318 | ADHESE UNIVERSAL | Ivoclar Vivadent, AG | 2014-02-11 | Traditional | PDF ↗ |
| K132923 | FUSION SINGLE LINK | Angelus Industria DE Productos Odontologicos SA | 2014-01-03 | Traditional | PDF ↗ |
| K133078 | K-ETCHANT SYRINGE; NEEDLE TIP (E) | Kuraray Noritake Dental, Inc. | 2013-12-20 | Traditional | PDF ↗ |
| K132450 | CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND | Kuraray Noritake Dental, Inc. | 2013-11-01 | Traditional | PDF ↗ |
| K131043 | APEX UNIVERSAL ADHESIVE | Apex Dental Materials, Inc. | 2013-09-10 | Traditional | PDF ↗ |
| K131357 | PEAK Z | Ultradent Products, Inc. | 2013-09-06 | Traditional | PDF ↗ |
| K131430 | CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL | Kuraray Noritake Dental, Inc. | 2013-08-30 | Traditional | PDF ↗ |
| K131049 | ZRP | Apex Dental Materials, Inc. | 2013-08-27 | Traditional | PDF ↗ |
| K131212 | PREMIER CERAMIC PRIMER | Premier Dental Products Co. | 2013-08-26 | Traditional | PDF ↗ |
| 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. | 2013-08-22 | Traditional | PDF ↗ |
| K131248 | ETCH GEL | Dmg America, LLC | 2013-07-11 | Traditional | PDF ↗ |
| K130486 | FUTURABOND UNIVERSAL | Voco GmbH | 2013-06-20 | Traditional | PDF ↗ |
| K122522 | DENTOETCH QUICKBOND BOND ACTIVATOR | Itena Clinical | 2013-03-19 | Traditional | PDF ↗ |
| K123278 | IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF | Heraeus Kulzer, LLC | 2012-12-07 | Special | PDF ↗ |
| K123119 | CERARESIN BOND | Shofu Dental Corporation | 2012-11-28 | Traditional | PDF ↗ |
| K120620 | CLEAN AND BOOST | Apex Dental Materials, Inc. | 2012-05-31 | Traditional | PDF ↗ |
| K120767 | ES BOND | Spident Co., Ltd. | 2012-05-24 | Traditional | PDF ↗ |
| K120213 | ETCH-RITE SUPREME | Pulpdent Corporation | 2012-03-30 | Traditional | PDF ↗ |
| K112597 | SEITY 37% PHOSPHORIC ACID ETCHANT GEL | Mycone Dental Supply Co., Inc. | 2011-12-07 | Traditional | PDF ↗ |
| K112118 | DREAMBOND | Bisco, Inc. | 2011-11-17 | Traditional | PDF ↗ |
| K111980 | CLEARFIL TRI-S BOND PLUS | Kuraray America, Inc. | 2011-10-14 | Traditional | PDF ↗ |
| K111975 | CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK | Kuraray Medical, Inc. | 2011-10-14 | Traditional | PDF ↗ |
| K111876 | Z BOND, PRELUDE ONE | Danville Materials, Inc. | 2011-09-21 | Traditional | PDF ↗ |
| K110403 | PROLINK ADHESIVES (PROLINK, PROLINK SE) | Silmet , Ltd. | 2011-09-08 | Traditional | PDF ↗ |
| K111431 | B1P ADHESIVE | Pentron Clinical | 2011-08-01 | Traditional | PDF ↗ |
Product code KLE · Class II · Dental. Data: openFDA.