Product code KLE
- Device name
- Agent, Tooth Bonding, Resin
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.3200
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260485 | Any-Etch | Mediclus Co., Ltd. | 2026-05-14 |
| K260430 | Porcelain Etch Gel | Belport Company, Inc., Gingi-Pak | 2026-04-10 |
| K252450 | Adhese 2 | Ivoclar Vivadent, Inc. | 2026-03-05 |
| K260682 | Bond-PR™ Universal Adhesive | Premier Dental Products Company | 2026-03-03 |
| K251587 | VITA VMLC Primer | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 2026-02-23 |
| K252151 | els unibond | Saremco Dental AG | 2025-12-05 |
| K252469 | MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA | Dmp Dental Industry S.A. | 2025-11-06 |
| K251124 | G-Bond Universal | GC America, Inc. | 2025-10-02 |
| K242530 | HF-Etchant Hydrofluoric Acid Etching Gel | Rizhao Huge Biomaterials Company, Ltd. | 2024-12-20 |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling Agent | Rizhao Huge Biomaterials Company, Ltd. | 2024-11-08 |
| 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. | 2024-11-01 |
| K240153 | Ceramic Etchant (HF-5 and HF-9) | Liaoning Upcera Co., Ltd. | 2024-10-02 |
| K241445 | K-Bond Universal | Spident Co., Ltd. | 2024-07-22 |
| K241056 | Light Cure Adhesive | Sincera Technology (Changchun) Co., Ltd. | 2024-07-16 |
| K240743 | Peak Universal Bond | Ultradent Products, Inc. | 2024-03-20 |
| K231039 | CLEARFIL Universal Bond Quick 2 | Kuraray Noritake Dental, Inc. | 2023-12-13 |
| K232978 | DX. Bond V Dental Bonding Adhesive | Sino-Dentex Co., Ltd. | 2023-09-22 |
| K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal | Prevest Denpro Limited | 2023-08-11 |
| K230465 | Hi-Bond Universal | Mediclus Co., Ltd. | 2023-05-22 |
| K230009 | EZ Bond Universal | Meta Biomed Co., Ltd. | 2023-03-03 |
| K222830 | Rainbow 360 | Kerr Corporation | 2023-01-12 |
| K221450 | Phosphoric Acid Etching Gel | Rizhao Huge Biomaterials Company, Ltd. | 2022-09-12 |
| K222357 | DenMat Glutaraldehyde Desensitizer | Denmat Holding, LLC | 2022-08-09 |
| K221033 | UniPrime A, UniPrime E, UniPrime E/C | S&C Polymer Silicon- Und Composite Spezialitäten GmbH | 2022-07-06 |
| K220804 | Dia-X Bond Universal | DiaDent Group International | 2022-06-15 |
| K210804 | Adhese Universal DC, Cention Primer | Ivoclar Vivadent, AG | 2022-06-07 |
| K213965 | BeautiBond Xtreme | Shofu Dental Corporation | 2022-03-18 |
| K213401 | DIAPLUS Universal | DiaDent Group International | 2022-01-31 |
| K213093 | STEP-1 PumEtch | Rounding Third, LLC | 2022-01-28 |
| K210186 | PacBond One | Pac-Dent, Inc. | 2021-07-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07615208298536 | Monobond Plus | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2024-01-24 |
| 07615208293128 | Adhese 100 | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-04-06 |
| 07615208295375 | Monobond Etch & Prime | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-04-06 |
| 07615208296136 | Adhese Universal | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-04-06 |
| 07615208296143 | Adhese Universal | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-04-06 |
| 07615208297362 | ExciTE F | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-04-06 |
| 07615208297379 | ExciTE F | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-04-06 |
| 07615208302684 | Syntac | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2023-03-29 |
| 07615208434187 | ExciTE F DSC | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2022-09-29 |
| 07615208434194 | ExciTE F DSC | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2022-09-29 |
| 07615208434200 | ExciTE F | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2022-09-29 |
| 07615208008630 | Heliobond | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2022-08-22 |
| 07615208008609 | Syntac | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2022-08-22 |
| 07899633816552 | Allcem Veneer APS | Dentscare Ltda | 2020-09-14 |
| J001SUGLUE3KIT0 | 3M™ | 3M Deutschland GmbH | 2019-11-20 |
| J001ADH19KIT20 | 3M™ | 3M Deutschland GmbH | 2019-11-18 |
| 08809254450416 | DenFil | VERICOM CO., LTD. | 2016-11-01 |
| J001702011387010 | RelyX™ Ultimate | 3M Deutschland GmbH | 2016-09-24 |
| J001702011387190 | RelyX™ Ultimate | 3M Deutschland GmbH | 2016-09-24 |
| J001702011387350 | RelyX™ Ultimate | 3M Deutschland GmbH | 2016-09-24 |
| J001702011389900 | Scotchbond™ Universal | 3M Deutschland GmbH | 2016-09-24 |
| J001702011390060 | Scotchbond™ Universal | 3M Deutschland GmbH | 2016-09-24 |
| J001702011390140 | Scotchbond™ Universal | 3M Deutschland GmbH | 2016-09-24 |
| J001702011390220 | Scotchbond™ Universal | 3M Deutschland GmbH | 2016-09-24 |
| J001702011390630 | Scotchbond™ Universal Etchant | 3M Deutschland GmbH | 2016-09-24 |
| J001702011441210 | Scotchbond™ Universal Etchant | 3M Deutschland GmbH | 2016-09-24 |
| J001702011443030 | 3M™ | 3M Deutschland GmbH | 2016-09-24 |
| J001702011129120 | CoJet™ | 3M Deutschland GmbH | 2016-09-24 |
| J001702011045130 | Ketac™ Glaze | 3M Deutschland GmbH | 2016-09-24 |
| J001702011005450 | CoJet™ Sand | 3M Deutschland GmbH | 2016-09-24 |