FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
K-Bond Universal
K Number: K241445
·
Decision Jul 22, 2024
Classifications
1
FEI Numbers
133
Registration Numbers
133
Same Product Code
410
Applicant Total
4
Review Days
61
Basic Information
- Device Name
- K-Bond Universal
- K Number
- K241445
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spident Co., Ltd.
- Date Received
- May 22, 2024
- Decision Date
- July 22, 2024
- Product Code
- KLE
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLE), ordered by most recent decision date.
HF-Etchant Hydrofluoric Acid Etching Gel
FDA 510(k)
FDA Class 2
·Dental
TopCEM Ceramic Primer Ceramic Coupling Agent
FDA 510(k)
FDA Class 2
·Dental
FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)
FDA 510(k)
FDA Class 2
·Dental
Ceramic Etchant (HF-5 and HF-9)
FDA 510(k)
FDA Class 2
·Dental
Light Cure Adhesive
FDA 510(k)
FDA Class 2
·Dental
Peak Universal Bond
FDA 510(k)
FDA Class 2
·Dental