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FDA 510(k)

VITA VMLC Primer

K-Number: K251587 · 2026-02-23

Decision Date2026-02-23
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VITA VMLC Primer is a medical device manufactured by Vita Zahnfabrik H. Rauter GmbH & Co. Kg.. It received FDA 510(k) clearance on 2026-02-23 under approval 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. It is manufactured by Vita Zahnfabrik H. Rauter GmbH & Co. Kg.. The 510(k) number is K251587.

When was VITA VMLC Primer approved by the FDA?

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

What company makes VITA VMLC Primer?

VITA VMLC Primer is manufactured by Vita Zahnfabrik H. Rauter GmbH & Co. Kg..

What is the FDA product code for VITA VMLC Primer?

The FDA product code for VITA VMLC Primer is KLE.

Related Devices (Code: KLE)

Official Source

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