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FDA 510(k)

MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA

K-Number: K252469 · 2025-11-06

ApplicantDmp Dental Industry S.A.
Decision Date2025-11-06
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA is a medical device manufactured by Dmp Dental Industry S.A.. It received FDA 510(k) clearance on 2025-11-06 under approval number K252469. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA?

MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA is a medical device that received FDA 510(k) clearance on 2025-11-06. It is manufactured by Dmp Dental Industry S.A.. The 510(k) number is K252469.

When was MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA approved by the FDA?

MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA received FDA 510(k) clearance on 2025-11-06, under approval number K252469.

What company makes MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA?

MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA is manufactured by Dmp Dental Industry S.A..

What is the FDA product code for MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA?

The FDA product code for MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA is KLE.

Other Devices by Dmp Dental Industry S.A.

K192830Bright Temporary C&B K253248Bright Cavity Liner

Related Devices (Code: KLE)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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