Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KLE — Predicate Candidate Screening
419 FDA 510(k) clearances under this product code; the 50 most recent screened below.
70 daysmedian FDA review time
154 days90th percentile
419clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260485 | Any-Etch | Mediclus Co., Ltd. | 2026-05-14 | 90 | 0 |
| K260430 | Porcelain Etch Gel | Belport Company, Inc., Gingi-Pak | 2026-04-10 | 59 | 0 |
| K252450 | Adhese 2 | Ivoclar Vivadent, Inc. | 2026-03-05 | 213 | 0 |
| K260682 | Bond-PR™ Universal Adhesive | Premier Dental Products Company | 2026-03-03 | 1 | 0 |
| K251587 | VITA VMLC Primer | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 2026-02-23 | 276 | 0 |
| K252151 | els unibond | Saremco Dental AG | 2025-12-05 | 149 | 0 |
| K252469 | MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA | Dmp Dental Industry S.A. | 2025-11-06 | 92 | 0 |
| K251124 | G-Bond Universal | GC America, Inc. | 2025-10-02 | 174 | 0 |
| K242530 | HF-Etchant Hydrofluoric Acid Etching Gel | Rizhao Huge Biomaterials Company, Ltd. | 2024-12-20 | 116 | 0 |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling Agent | Rizhao Huge Biomaterials Company, Ltd. | 2024-11-08 | 57 | 0 |
| K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1. | Spident Co., Ltd. | 2024-11-01 | 56 | 0 |
| K240153 | Ceramic Etchant (HF-5 and HF-9) | Liaoning Upcera Co., Ltd. | 2024-10-02 | 257 | 0 |
| K241445 | K-Bond Universal | Spident Co., Ltd. | 2024-07-22 | 61 | 0 |
| K241056 | Light Cure Adhesive | Sincera Technology (Changchun) Co., Ltd. | 2024-07-16 | 89 | 0 |
| K240743 | Peak Universal Bond | Ultradent Products, Inc. | 2024-03-20 | 2 | 0 |
| K231039 | CLEARFIL Universal Bond Quick 2 | Kuraray Noritake Dental, Inc. | 2023-12-13 | 245 | 0 |
| K232978 | DX. Bond V Dental Bonding Adhesive | Sino-Dentex Co., Ltd. | 2023-09-22 | 1 | 0 |
| K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Ren | Prevest Denpro Limited | 2023-08-11 | 60 | 0 |
| K230465 | Hi-Bond Universal | Mediclus Co., Ltd. | 2023-05-22 | 90 | 0 |
| K230009 | EZ Bond Universal | Meta Biomed Co., Ltd. | 2023-03-03 | 59 | 0 |
| K222830 | Rainbow 360 | Kerr Corporation | 2023-01-12 | 115 | 0 |
| K221450 | Phosphoric Acid Etching Gel | Rizhao Huge Biomaterials Company, Ltd. | 2022-09-12 | 117 | 0 |
| K222357 | DenMat Glutaraldehyde Desensitizer | Denmat Holding, LLC | 2022-08-09 | 5 | 0 |
| K221033 | UniPrime A, UniPrime E, UniPrime E/C | S&C Polymer Silicon- Und Composite Spezialitäten GmbH | 2022-07-06 | 90 | 0 |
| K220804 | Dia-X Bond Universal | DiaDent Group International | 2022-06-15 | 89 | 0 |
| K210804 | Adhese Universal DC, Cention Primer | Ivoclar Vivadent, AG | 2022-06-07 | 447 | 0 |
| K213965 | BeautiBond Xtreme | Shofu Dental Corporation | 2022-03-18 | 88 | 0 |
| K213401 | DIAPLUS Universal | DiaDent Group International | 2022-01-31 | 105 | 0 |
| K213093 | STEP-1 PumEtch | Rounding Third, LLC | 2022-01-28 | 126 | 0 |
| K210186 | PacBond One | Pac-Dent, Inc. | 2021-07-16 | 172 | 0 |
| K210945 | Ultra SEP | Reliance Orthodontic Products, Inc. | 2021-07-08 | 100 | 0 |
| K203760 | Tokuyama Universal Bond II | Tokuyama Dental Corporation | 2021-05-25 | 153 | 0 |
| K192913 | R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2021-01-19 | 462 | 0 |
| K200153 | Bright Bond Universal | Genoss Co., Ltd. | 2020-10-28 | 280 | 0 |
| K200682 | BZF-29 | GC America, Inc. | 2020-10-02 | 200 | 0 |
| K201787 | Light Cure Dental Adhesive | Rizhao Huge Biomaterials Company, Ltd. | 2020-09-25 | 87 | 0 |
| K200462 | EtchPro Etching Gel | Belport Company, Inc., Gingi-Pak | 2020-09-02 | 190 | 0 |
| K192392 | DiaPlus | DiaDent Group International | 2020-05-26 | 266 | 0 |
| K192273 | DIAETCH Economic Package Type A, DIATECH Regular Package, DI | DiaDent Group International | 2020-02-07 | 169 | 0 |
| K183424 | Ambar, Ambar APS, Ambar Universal APS | Dentscare Ltda | 2019-12-13 | 367 | 0 |
| K191656 | Zipbond | Sdi Limited | 2019-12-02 | 164 | 0 |
| K192961 | ADH19 | 3M Deutschland GmbH | 2019-10-31 | 9 | 0 |
| K191523 | Visalys Restorative Primer | Kettenbach GmbH & Co. KG | 2019-10-09 | 121 | 0 |
| K191524 | Visalys Tooth Primer | Kettenbach GmbH & Co. KG | 2019-09-29 | 111 | 0 |
| K183391 | Novidia Universal Bond | Nobio , Ltd. | 2019-09-24 | 291 | 0 |
| K180917 | GC Acrylic Primer | GC America, Inc. | 2018-11-20 | 225 | 0 |
| K182162 | OptiBond eXTRa Universal | Kerr Corporation | 2018-11-07 | 89 | 0 |
| K181910 | BracePaste MTP Light Cure Primer | American Orthodontics | 2018-10-15 | 90 | 0 |
| K181476 | Prime&Bond active Universal Adhesive | Dentsply Sirona | 2018-09-28 | 115 | 0 |
| K180803 | BeautiBond Universal | Shofu Dental Corporation | 2018-09-26 | 182 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda