FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇷 Greece
MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA
K Number: K252469
·
Decision Nov 6, 2025
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
3
Review Days
92
Basic Information
- Device Name
- MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA
- K Number
- K252469
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dmp Dental Industry S.A.
- Date Received
- August 6, 2025
- Decision Date
- November 6, 2025
- 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 |
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