Magnabond Se; Magnabond Universal; Magnabond Universal Dca

Q: What is the product code of K252469?

The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.

FDA 510(k) K252469 · Dmp Dental Industry S.A.

Substantially Equivalent

510(k) numberK252469

Submission

Device name: Magnabond Se; Magnabond Universal; Magnabond Universal Dca
Applicant: Dmp Dental Industry S.A.
Markopoulo, GR
Received: August 6, 2025
Decision date: November 6, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: KLE – Agent, Tooth Bonding, Resin
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.3200
Specialty: Dental

Other 510(k)s with product code KLE

510(k)	Device	Applicant	Decision
K260485	Any-EtchKLE · Traditional	Mediclus Co., Ltd.	05/14/2026SE
K260430	Porcelain Etch GelKLE · Traditional	Belport Company, Inc., Gingi-Pak	04/10/2026SE
K252450	Adhese 2KLE · Traditional	Ivoclar Vivadent, Inc.	03/05/2026SE
K260682	Bond-PR Universal AdhesiveKLE · Traditional	Premier Dental Products Company	03/03/2026SE
K251587	VITA VMLC PrimerKLE · Traditional	Vita Zahnfabrik H. Rauter GmbH & Co. Kg.	02/23/2026SE
K252151	els unibondKLE · Traditional	Saremco Dental AG	12/05/2025SE
K251124	G-Bond UniversalKLE · Traditional	GC America, Inc.	10/02/2025SE
K242530	HF-Etchant Hydrofluoric Acid Etching GelKLE · Traditional	Rizhao Huge Biomaterials Company, Ltd.	12/20/2024SE
K242749	TopCEM Ceramic Primer Ceramic Coupling AgentKLE · Traditional	Rizhao Huge Biomaterials Company, Ltd.	11/08/2024SE
K242675	FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml…KLE · Traditional	Spident Co., Ltd.	11/01/2024SE

More from Spident Co., Ltd.

510(k)	Device	Decision
K253248	Bright Cavity LinerEJK · Traditional	01/13/2026SE
K192830	Bright Temporary C&BEBG · Traditional	09/02/2020SE

Questions and answers

When was Magnabond Se; Magnabond Universal; Magnabond Universal Dca cleared by the FDA?

Magnabond Se; Magnabond Universal; Magnabond Universal Dca (K252469) received a 510(k) decision of Substantially Equivalent on November 6, 2025, 92 days after the submission was received.

What is the product code of K252469?

The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.