KLE · Agent, Tooth Bonding, Resin
Dental · 21 CFR 872.3200 · Class 2
Overview
| Product Code | KLE |
|---|---|
| Device Name | Agent, Tooth Bonding, Resin |
| Regulation | 21 CFR 872.3200 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 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 | Porcelain Etch Gel | Belport Company, Inc., Gingi-Pak | Apr 10, 2026 | SESE |
| K252450 | Adhese 2 | Ivoclar Vivadent, Inc. | Mar 5, 2026 | SESE |
| K260682 | Bond-PR Universal Adhesive | Premier Dental Products Company | Mar 3, 2026 | SESE |
| K251587 | VITA VMLC Primer | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | Feb 23, 2026 | SESE |
| K252151 | els unibond | Saremco Dental AG | Dec 5, 2025 | SESE |
| K252469 | MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA | Dmp Dental Industry S.A. | Nov 6, 2025 | SESE |
| K251124 | G-Bond Universal | GC America, Inc. | Oct 2, 2025 | SESE |
| K242530 | HF-Etchant Hydrofluoric Acid Etching Gel | Rizhao Huge Biomaterials Company, Ltd. | Dec 20, 2024 | SESE |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling Agent | Rizhao Huge Biomaterials Company, Ltd. | Nov 8, 2024 | SESE |
| 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. | Nov 1, 2024 | SESE |
| K240153 | Ceramic Etchant (HF-5 and HF-9) | Liaoning Upcera Co., Ltd. | Oct 2, 2024 | SESE |
| K241445 | K-Bond Universal | Spident Co., Ltd. | Jul 22, 2024 | SESE |
| K241056 | Light Cure Adhesive | Sincera Technology (Changchun) Co., Ltd. | Jul 16, 2024 | SESE |
| K240743 | Peak Universal Bond | Ultradent Products, Inc. | Mar 20, 2024 | SESE |
| K231039 | CLEARFIL Universal Bond Quick 2 | Kuraray Noritake Dental, Inc. | Dec 13, 2023 | SESE |
| K232978 | DX. Bond V Dental Bonding Adhesive | Sino-Dentex Co., Ltd. | Sep 22, 2023 | SESE |
| K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal | Prevest Denpro Limited | Aug 11, 2023 | SESE |
| K230465 | Hi-Bond Universal | Mediclus Co., Ltd. | May 22, 2023 | SESE |
| K230009 | EZ Bond Universal | Meta Biomed Co., Ltd. | Mar 3, 2023 | SESE |
| K222830 | 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
