Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3200](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3200) → KLE — Agent, Tooth Bonding, Resin # KLE · Agent, Tooth Bonding, Resin _Dental · 21 CFR 872.3200 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE ## Overview - **Product Code:** KLE - **Device Name:** Agent, Tooth Bonding, Resin - **Regulation:** [21 CFR 872.3200](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3200) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **3rd-party reviewable:** yes ## Identification A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 418) Showing 20 most recent of 418 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260430](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K260430.md) | Porcelain Etch Gel | Belport Company, Inc., Gingi-Pak | Apr 10, 2026 | SESE | | [K252450](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K252450.md) | Adhese 2 | Ivoclar Vivadent, Inc. | Mar 5, 2026 | SESE | | [K260682](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K260682.md) | Bond-PR™ Universal Adhesive | Premier Dental Products Company | Mar 3, 2026 | SESE | | [K251587](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K251587.md) | VITA VMLC Primer | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | Feb 23, 2026 | SESE | | [K252151](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K252151.md) | els unibond | Saremco Dental AG | Dec 5, 2025 | SESE | | [K252469](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K252469.md) | MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA | Dmp Dental Industry S.A. | Nov 6, 2025 | SESE | | [K251124](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K251124.md) | G-Bond Universal | GC America, Inc. | Oct 2, 2025 | SESE | | [K242530](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K242530.md) | HF-Etchant Hydrofluoric Acid Etching Gel | Rizhao Huge Biomaterials Company, Ltd. | Dec 20, 2024 | SESE | | [K242749](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K242749.md) | TopCEM Ceramic Primer Ceramic Coupling Agent | Rizhao Huge Biomaterials Company, Ltd. | Nov 8, 2024 | SESE | | [K242675](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K242675.md) | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) | Spident Co., Ltd. | Nov 1, 2024 | SESE | | [K240153](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K240153.md) | Ceramic Etchant (HF-5 and HF-9) | Liaoning Upcera Co., Ltd. | Oct 2, 2024 | SESE | | [K241445](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K241445.md) | K-Bond Universal | Spident Co., Ltd. | Jul 22, 2024 | SESE | | [K241056](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K241056.md) | Light Cure Adhesive | Sincera Technology (Changchun) Co., Ltd. | Jul 16, 2024 | SESE | | [K240743](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K240743.md) | Peak Universal Bond | Ultradent Products, Inc. | Mar 20, 2024 | SESE | | [K231039](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K231039.md) | CLEARFIL Universal Bond Quick 2 | Kuraray Noritake Dental, Inc. | Dec 13, 2023 | SESE | | [K232978](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K232978.md) | DX. Bond V Dental Bonding Adhesive | Sino-Dentex Co., Ltd. | Sep 22, 2023 | SESE | | [K231696](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K231696.md) | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal | Prevest Denpro Limited | Aug 11, 2023 | SESE | | [K230465](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K230465.md) | Hi-Bond Universal | Mediclus Co., Ltd. | May 22, 2023 | SESE | | [K230009](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K230009.md) | EZ Bond Universal | Meta Biomed Co., Ltd. | Mar 3, 2023 | SESE | | [K222830](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE/K222830.md) | Rainbow 360 | Kerr Corporation | Jan 12, 2023 | SESE | ## Top Applicants - Dentsply Intl. — 20 clearances - Ultradent Products, Inc. — 19 clearances - Bisco, Inc. — 18 clearances - Heraeus Kulzer, Inc. — 16 clearances - Kuraray Medical, Inc. — 14 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KLE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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