510(k) K983414
- Device
- EVERBOND
- Applicant
- ESPE DENTAL AG
- 510(k) number
- K983414
- Product code
- KLE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-12-16
- Date received
- 1998-09-28
- Regulation
- 872.3200
- Classification name
- Agent, Tooth Bonding, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Clearance type
- Traditional
- Third party reviewed
- No
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| 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 |
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| 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 |
Legacy Summary#
summary
FDA Review#
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