VITA VMLC Primer
FDA 510(k) K251587 · Vita Zahnfabrik H. Rauter GmbH & Co. Kg.
510(k) numberK251587
Submission
- Device name
- VITA VMLC Primer
- Applicant
- Vita Zahnfabrik H. Rauter GmbH & Co. Kg.
Baden-Wurttemberg, DE - Received
- May 23, 2025
- Decision date
- February 23, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was VITA VMLC Primer cleared by the FDA?
VITA VMLC Primer (K251587) received a 510(k) decision of Substantially Equivalent on February 23, 2026, 276 days after the submission was received.
What is the product code of K251587?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.