FDA 510(k)

VITA VMLC Primer

K-Number: K251587 · 2026-02-23

ApplicantVita Zahnfabrik H. Rauter GmbH & Co. Kg.

Decision Date2026-02-23

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

VITA VMLC Primer is the device name listed in this FDA 510(k) record. The listed applicant is Vita Zahnfabrik H. Rauter GmbH & Co. Kg.. It received FDA 510(k) clearance on 2026-02-23 under 510(k) number K251587. 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 VITA VMLC Primer?

VITA VMLC Primer is a medical device that received FDA 510(k) clearance on 2026-02-23. The listed applicant is Vita Zahnfabrik H. Rauter GmbH & Co. Kg.. The 510(k) number is K251587.

When did VITA VMLC Primer receive FDA 510(k) clearance?

VITA VMLC Primer received FDA 510(k) clearance on 2026-02-23, under 510(k) number K251587.

Who is the listed applicant for VITA VMLC Primer?

The FDA 510(k) record lists Vita Zahnfabrik H. Rauter GmbH & Co. Kg. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITA VMLC Primer?

The FDA product code for VITA VMLC Primer is KLE.

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-Pak K252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products Company K252151els unibondSaremco Dental AG K252469MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCADmp Dental Industry S.A.

Official Source

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