KLE
- Product code
- KLE
- Device name
- Agent, Tooth Bonding, Resin
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.3200
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 17
- Summaries archived here
- 11 (direct download)
- 510(k) clearances (all years, FDA)
- 419 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (17)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260485 | 2026-05-14 | Mediclus Co., Ltd. | Any-Etch | |
| K260430 | 2026-04-10 | Belport Company, Inc., Gingi-Pak | Porcelain Etch Gel | — |
| K252450 | 2026-03-05 | Ivoclar Vivadent, Inc. | Adhese 2 | |
| K260682 | 2026-03-03 | Premier Dental Products Company | Bond-PR Universal Adhesive | |
| K251587 | 2026-02-23 | Vita Zahnfabrik H. Rauter GmbH & Co. K… | VITA VMLC Primer | FDA |
| K252151 | 2025-12-05 | Saremco Dental AG | els unibond | |
| K252469 | 2025-11-06 | Dmp Dental Industry S.A. | MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERS… | — |
| K251124 | 2025-10-02 | GC America, Inc. | G-Bond Universal | |
| K242530 | 2024-12-20 | Rizhao Huge Biomaterials Company, Ltd. | HF-Etchant Hydrofluoric Acid Etching Gel | |
| K242749 | 2024-11-08 | Rizhao Huge Biomaterials Company, Ltd. | TopCEM Ceramic Primer Ceramic Coupling Agent | |
| K242675 | 2024-11-01 | Spident Co., Ltd. | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEt… | |
| K240153 | 2024-10-02 | Liaoning Upcera Co., Ltd. | Ceramic Etchant (HF-5 and HF-9) | — |
| K241445 | 2024-07-22 | Spident Co., Ltd. | K-Bond Universal | |
| K241056 | 2024-07-16 | Sincera Technology (Changchun) Co., Lt… | Light Cure Adhesive | — |
| K240743 | 2024-03-20 | Ultradent Products, Inc. | Peak Universal Bond | |
| K231039 | 2023-12-13 | Kuraray Noritake Dental, Inc. | CLEARFIL Universal Bond Quick 2 | |
| K232978 | 2023-09-22 | Sino-Dentex Co., Ltd. | DX. Bond V Dental Bonding Adhesive | FDA |
Official FDA classification page: KLE
Classification and pathway per current FDA publications. Data from openFDA (CC0).