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 |
|---|---|---|---|
| Oct 8, 2026 | K263680 | One Coat Bond; One Coat Bond SL Dent4You AG, CH | KLE |
| Sep 24, 2026 | K262252 | MPa Max adhesive Den-Mat Holdings, LLC | KLE |
| May 14, 2026 | K260485 | Any-Etch Mediclus Co., Ltd., KR | KLE |
| Apr 10, 2026 | K260430 | Porcelain Etch Gel Belport Company, Inc., Gingi-Pak | KLE |
| Mar 5, 2026 | K252450 | Adhese 2 Ivoclar Vivadent, Inc. | KLE |
| Mar 3, 2026 | K260682 | Bond-PR Universal Adhesive Premier Dental Products Company | KLE |
| Feb 23, 2026 | K251587 | VITA VMLC Primer Vita Zahnfabrik H. Rauter GmbH & Co. Kg., DE | KLE |
| Dec 5, 2025 | K252151 | els unibond Saremco Dental AG, CH | KLE |
| Nov 6, 2025 | K252469 | MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA Dmp Dental Industry S.A., GR | KLE |
| Oct 2, 2025 | K251124 | G-Bond Universal GC America, Inc. | KLE |
| Dec 20, 2024 | K242530 | HF-Etchant Hydrofluoric Acid Etching Gel Rizhao Huge Biomaterials Company, Ltd., CN | KLE |
| Nov 8, 2024 | K242749 | TopCEM Ceramic Primer Ceramic Coupling Agent Rizhao Huge Biomaterials Company, Ltd., CN | KLE |
| Nov 1, 2024 | 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., KR | KLE |
| Oct 2, 2024 | K240153 | Ceramic Etchant (HF-5 and HF-9) Liaoning Upcera Co., Ltd., CN | KLE |
| Jul 22, 2024 | K241445 | K-Bond Universal Spident Co., Ltd., KR | KLE |
| Jul 16, 2024 | K241056 | Light Cure Adhesive Sincera Technology (Changchun) Co., Ltd., CN | KLE |
| Mar 20, 2024 | K240743 | Peak Universal Bond Ultradent Products, Inc. | KLE |
| Dec 13, 2023 | K231039 | CLEARFIL Universal Bond Quick 2 Kuraray Noritake Dental, Inc., JP | KLE |
| Sep 22, 2023 | K232978 | DX. Bond V Dental Bonding Adhesive Sino-Dentex Co., Ltd. | KLE |
| Aug 11, 2023 | K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal Prevest Denpro Limited, IN | KLE |
| May 22, 2023 | K230465 | Hi-Bond Universal Mediclus Co., Ltd., KR | KLE |
| Mar 3, 2023 | K230009 | EZ Bond Universal Meta Biomed Co., Ltd., KR | KLE |
| Jan 12, 2023 | K222830 | Rainbow 360 Kerr Corporation | KLE |
| Sep 12, 2022 | K221450 | Phosphoric Acid Etching Gel Rizhao Huge Biomaterials Company, Ltd., CN | KLE |
| Aug 9, 2022 | K222357 | DenMat Glutaraldehyde Desensitizer Denmat Holding, LLC | KLE |
| Jul 6, 2022 | K221033 | UniPrime A, UniPrime E, UniPrime E/C S&C Polymer Silicon- Und Composite Spezialitäten GmbH, DE | KLE |
| Jun 15, 2022 | K220804 | Dia-X Bond Universal DiaDent Group International, KR | KLE |
| Jun 7, 2022 | K210804 | Adhese Universal DC, Cention Primer Ivoclar Vivadent, AG, LI | KLE |
| Mar 18, 2022 | K213965 | BeautiBond Xtreme Shofu Dental Corporation | KLE |
| Jan 31, 2022 | K213401 | DIAPLUS Universal DiaDent Group International, KR | KLE |
| Jan 28, 2022 | K213093 | STEP-1 PumEtch Rounding Third, LLC | KLE |
| Jul 16, 2021 | K210186 | PacBond One Pac-Dent, Inc. | KLE |
| Jul 8, 2021 | K210945 | Ultra SEP Reliance Orthodontic Products, Inc. | KLE |
| May 25, 2021 | K203760 | Tokuyama Universal Bond II Tokuyama Dental Corporation, JP | KLE |
| Jan 19, 2021 | 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, TR | KLE |
| Oct 28, 2020 | K200153 | Bright Bond Universal Genoss Co., Ltd., KR | KLE |
| Oct 2, 2020 | K200682 | BZF-29 GC America, Inc. | KLE |
| Sep 25, 2020 | K201787 | Light Cure Dental Adhesive Rizhao Huge Biomaterials Company, Ltd., CN | KLE |
| Sep 2, 2020 | K200462 | EtchPro Etching Gel Belport Company, Inc., Gingi-Pak | KLE |
| May 26, 2020 | K192392 | DiaPlus DiaDent Group International, KR | KLE |
| Feb 7, 2020 | K192273 | DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit DiaDent Group International, KR | KLE |
| Dec 13, 2019 | K183424 | Ambar, Ambar APS, Ambar Universal APS Dentscare Ltda, BR | KLE |
| Dec 2, 2019 | K191656 | Zipbond Sdi Limited, AU | KLE |
| Oct 31, 2019 | K192961 | ADH19 3M Deutschland GmbH, DE | KLE |
| Oct 9, 2019 | K191523 | Visalys Restorative Primer Kettenbach GmbH & Co. KG, DE | KLE |
| Sep 29, 2019 | K191524 | Visalys Tooth Primer Kettenbach GmbH & Co. KG, DE | KLE |
| Sep 24, 2019 | K183391 | Novidia Universal Bond Nobio , Ltd., IL | KLE |
| Nov 20, 2018 | K180917 | GC Acrylic Primer GC America, Inc. | KLE |
| Nov 7, 2018 | K182162 | OptiBond eXTRa Universal Kerr Corporation | KLE |
| Oct 15, 2018 | K181910 | BracePaste MTP Light Cure Primer American Orthodontics | KLE |
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