K252469

MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA

510(k) number
K252469
Device name
MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA
Applicant
Dmp Dental Industry S.A. GR
Product code
KLE — Agent, Tooth Bonding, Resin
Decision date
2025-11-06
Date received
2025-08-06
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Dental
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K252469
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.