Atlas FDA

KLE

419 FDA 510(k) clearances · Product code

70 daysmedian time to decision
154 days90th percentile
419clearances measured

FDA profile

Official device name
Agent, Tooth Bonding, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3200
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2015: 100 · 2016: 47 · 2017: 42 · 2018: 31 · 2019: 20 · 2026: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Any-Etch (K260485)Mediclus Co., Ltd.2026-05-14
Porcelain Etch Gel (K260430)Belport Company, Inc., Gingi-Pak2026-04-10
Adhese 2 (K252450)Ivoclar Vivadent, Inc.2026-03-05
Bond-PR™ Universal Adhesive (K260682)Premier Dental Products Company2026-03-03
VITA VMLC Primer (K251587)Vita Zahnfabrik H. Rauter GmbH & Co. Kg.2026-02-23
els unibond (K252151)Saremco Dental AG2025-12-05
MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA (K252469)Dmp Dental Industry S.A.2025-11-06
G-Bond Universal (K251124)GC America, Inc.2025-10-02
HF-Etchant Hydrofluoric Acid Etching Gel (K242530)Rizhao Huge Biomaterials Company, Ltd.2024-12-20
TopCEM Ceramic Primer Ceramic Coupling Agent (K242749)Rizhao Huge Biomaterials Company, Ltd.2024-11-08
FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) (K242675)Spident Co., Ltd.2024-11-01
Ceramic Etchant (HF-5 and HF-9) (K240153)Liaoning Upcera Co., Ltd.2024-10-02
K-Bond Universal (K241445)Spident Co., Ltd.2024-07-22
Light Cure Adhesive (K241056)Sincera Technology (Changchun) Co., Ltd.2024-07-16
Peak Universal Bond (K240743)Ultradent Products, Inc.2024-03-20
CLEARFIL Universal Bond Quick 2 (K231039)Kuraray Noritake Dental, Inc.2023-12-13
DX. Bond V Dental Bonding Adhesive (K232978)Sino-Dentex Co., Ltd.2023-09-22
Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal (K231696)Prevest Denpro Limited2023-08-11
Hi-Bond Universal (K230465)Mediclus Co., Ltd.2023-05-22
EZ Bond Universal (K230009)Meta Biomed Co., Ltd.2023-03-03
Rainbow 360 (K222830)Kerr Corporation2023-01-12
Phosphoric Acid Etching Gel (K221450)Rizhao Huge Biomaterials Company, Ltd.2022-09-12
DenMat Glutaraldehyde Desensitizer (K222357)Denmat Holding, LLC2022-08-09
UniPrime A, UniPrime E, UniPrime E/C (K221033)S&C Polymer Silicon- Und Composite Spezialitäten GmbH2022-07-06
Dia-X Bond Universal (K220804)DiaDent Group International2022-06-15
Adhese Universal DC, Cention Primer (K210804)Ivoclar Vivadent, AG2022-06-07
BeautiBond Xtreme (K213965)Shofu Dental Corporation2022-03-18
DIAPLUS Universal (K213401)DiaDent Group International2022-01-31
STEP-1 PumEtch (K213093)Rounding Third, LLC2022-01-28
PacBond One (K210186)Pac-Dent, Inc.2021-07-16
Ultra SEP (K210945)Reliance Orthodontic Products, Inc.2021-07-08
Tokuyama Universal Bond II (K203760)Tokuyama Dental Corporation2021-05-25
R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose (K192913)Imicryl Dis Malzemeleri Sanayi VE Ticaret AS2021-01-19
Bright Bond Universal (K200153)Genoss Co., Ltd.2020-10-28
BZF-29 (K200682)GC America, Inc.2020-10-02
Light Cure Dental Adhesive (K201787)Rizhao Huge Biomaterials Company, Ltd.2020-09-25
EtchPro Etching Gel (K200462)Belport Company, Inc., Gingi-Pak2020-09-02
DiaPlus (K192392)DiaDent Group International2020-05-26
DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit (K192273)DiaDent Group International2020-02-07
Ambar, Ambar APS, Ambar Universal APS (K183424)Dentscare Ltda2019-12-13
Zipbond (K191656)Sdi Limited2019-12-02
ADH19 (K192961)3M Deutschland GmbH2019-10-31
Visalys Restorative Primer (K191523)Kettenbach GmbH & Co. KG2019-10-09
Visalys Tooth Primer (K191524)Kettenbach GmbH & Co. KG2019-09-29
Novidia Universal Bond (K183391)Nobio , Ltd.2019-09-24
GC Acrylic Primer (K180917)GC America, Inc.2018-11-20
OptiBond eXTRa Universal (K182162)Kerr Corporation2018-11-07
BracePaste MTP Light Cure Primer (K181910)American Orthodontics2018-10-15
Prime&Bond active Universal Adhesive (K181476)Dentsply Sirona2018-09-28
BeautiBond Universal (K180803)Shofu Dental Corporation2018-09-26
Meta P&Bond (K180802)Meta Biomed Co., Ltd.2018-08-29
Acid Etchant (K172953)American Orthodontics2018-02-06
Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel (K172977)Nanova Biomaterials, Inc.2018-01-16
TOKUYAMA UNIVERSAL BOND (K171226)Tokuyama Dental Corporation2017-11-28
Parkell Universal Adhesive (K172176)Parkell, Inc.2017-11-21
SHOFU MZ Primer Plus (K172106)Shofu Dental Corporation2017-08-31
RnD TE and RnD SE (K161077)Apex Dental Materials, Inc.2017-03-17
HC Primer (K161891)Shofu Dental Corporation2016-11-21
CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack (K161042)Kuraray Noritake Dental, Inc.2016-10-25
All-Bond Universal w/BAC (not finalized) (K161051)Bisco, Inc.2016-09-09
One Coat 7 Universal (K152243)Coltene/Whaledent AG2015-12-09
e-1 etchants (K152110)E Dental Products2015-11-20
Prime&Bond Elect Universal Dental Adhesive (K151619)Dentsply International, Inc.2015-10-30
BRUSH&BOND PLUS (K151518)Parkell, Inc.2015-09-18
CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial) (K150703)Kuraray Noritake Dental, Inc.2015-08-13
iBond Universal & iBond Ceramic Primer (K150933)Heraeus Kulzer, LLC, Mitsui Chemicals Group2015-07-07
Jade 37% Phosphoric Acid Etchant Gel (K150696)Dharma Research, Inc.2015-06-23
G-Premio BOND (K143140)GC America, Inc.2015-04-20
Monobond Etch & Prime (K150164)Ivoclar Vivadent, AG2015-04-03
EAZY PRIMER (K142848)Parkell, Inc.2015-02-24
PREMIER ETCH (K141839)Premier Dental Products Co.2014-11-17
TENURE4G (K140537)Den-Mat Holdings, LLC2014-08-20
FUTURABOND M+ (K141610)Voco GmbH2014-08-01
ALL-BOND UNIVERSAL SC (NOT FINALIZED) (K131734)Bisco, Inc.2014-04-11
ADHESE UNIVERSAL (K133318)Ivoclar Vivadent, AG2014-02-11
FUSION SINGLE LINK (K132923)Angelus Industria DE Productos Odontologicos SA2014-01-03
K-ETCHANT SYRINGE; NEEDLE TIP (E) (K133078)Kuraray Noritake Dental, Inc.2013-12-20
CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND (K132450)Kuraray Noritake Dental, Inc.2013-11-01
APEX UNIVERSAL ADHESIVE (K131043)Apex Dental Materials, Inc.2013-09-10
PEAK Z (K131357)Ultradent Products, Inc.2013-09-06
CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL (K131430)Kuraray Noritake Dental, Inc.2013-08-30
ZRP (K131049)Apex Dental Materials, Inc.2013-08-27
PREMIER CERAMIC PRIMER (K131212)Premier Dental Products Co.2013-08-26
CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL (K131432)Kuraray Noritake Dental, Inc.2013-08-22
ETCH GEL (K131248)Dmg America, LLC2013-07-11
FUTURABOND UNIVERSAL (K130486)Voco GmbH2013-06-20
DENTOETCH QUICKBOND BOND ACTIVATOR (K122522)Itena Clinical2013-03-19
IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF (K123278)Heraeus Kulzer, LLC2012-12-07
CERARESIN BOND (K123119)Shofu Dental Corporation2012-11-28
CLEAN AND BOOST (K120620)Apex Dental Materials, Inc.2012-05-31
ES BOND (K120767)Spident Co., Ltd.2012-05-24
ETCH-RITE SUPREME (K120213)Pulpdent Corporation2012-03-30
SEITY 37% PHOSPHORIC ACID ETCHANT GEL (K112597)Mycone Dental Supply Co., Inc.2011-12-07
DREAMBOND (K112118)Bisco, Inc.2011-11-17
CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK (K111975)Kuraray Medical, Inc.2011-10-14
CLEARFIL TRI-S BOND PLUS (K111980)Kuraray America, Inc.2011-10-14
Z BOND, PRELUDE ONE (K111876)Danville Materials, Inc.2011-09-21
PROLINK ADHESIVES (PROLINK, PROLINK SE) (K110403)Silmet , Ltd.2011-09-08
B1P ADHESIVE (K111431)Pentron Clinical2011-08-01
ADHESIVE EXL-759 (K110302)3M Espe AG2011-05-19
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