KLE — Agent, Tooth Bonding, Resin Class II
FDA product code KLE covers "Agent, Tooth Bonding, Resin", a Class II medical device regulated under 21 CFR 872.3200. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KLE
- Device Class
- Class II
- Regulation Number
- 872.3200
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260485 | mediclus co | Any-Etch | May 14, 2026 |
| K260430 | belport company, inc., gingi-pak | Porcelain Etch Gel | April 10, 2026 |
| K252450 | ivoclar vivadent | Adhese 2 | March 5, 2026 |
| K260682 | premier dental products | Bond-PR Universal Adhesive | March 3, 2026 |
| K251587 | vita zahnfabrik h. rauter gmbh and co. kg | VITA VMLC Primer | February 23, 2026 |
| K252151 | saremco dental | els unibond | December 5, 2025 |
| K252469 | dmp dental industry | MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA | November 6, 2025 |
| K251124 | gc america | G-Bond Universal | October 2, 2025 |
| K242530 | rizhao huge biomaterials company | HF-Etchant Hydrofluoric Acid Etching Gel | December 20, 2024 |
| K242749 | rizhao huge biomaterials company | TopCEM Ceramic Primer Ceramic Coupling Agent | November 8, 2024 |
| K242675 | spident co | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, | November 1, 2024 |
| K240153 | liaoning upcera co | Ceramic Etchant (HF-5 and HF-9) | October 2, 2024 |
| K241445 | spident co | K-Bond Universal | July 22, 2024 |
| K241056 | sincera technology (changchun) co | Light Cure Adhesive | July 16, 2024 |
| K240743 | ultradent products | Peak Universal Bond | March 20, 2024 |
| K231039 | kuraray noritake dental | CLEARFIL Universal Bond Quick 2 | December 13, 2023 |
| K232978 | sino-dentex co | DX. Bond V Dental Bonding Adhesive | September 22, 2023 |
| K231696 | prevest denpro limited | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal | August 11, 2023 |
| K230465 | mediclus co | Hi-Bond Universal | May 22, 2023 |
| K230009 | meta biomed co | EZ Bond Universal | March 3, 2023 |