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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 the device name listed in this FDA 510(k) record. The listed applicant is Dmp Dental Industry S.A.. It received FDA 510(k) clearance on 2025-11-06 under 510(k) 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. The listed applicant is Dmp Dental Industry S.A.. The 510(k) number is K252469.

When did MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA receive FDA 510(k) clearance?

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

Who is the listed applicant for MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA?

The FDA 510(k) record lists Dmp Dental Industry S.A. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Dmp Dental Industry S.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253248Bright Cavity LinerK192830Bright Temporary C&B

Related Devices (Code: KLE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.K252151els unibondSaremco Dental AG

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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