VITA VMLC Primer— 510(k) K251587
Substantially EquivalentVita Zahnfabrik H. Rauter GmbH & Co. Kg.
FDA 510(k) clearance K251587 for VITA VMLC Primer, Substantially Equivalent on 2026-02-23. Applicant: Vita Zahnfabrik H. Rauter GmbH & Co. Kg.. Device class: 2.
Summary
Vita Zahnfabrik H. Rauter GmbH & Co. KG filed VITA VMLC Primer under product code KLE, resin tooth bonding agent. The record doesn't describe the primer beyond its name and that code name.
Class II, 21 CFR 872.3200. Dental is both the classification panel and the review panel. It came in as a Traditional 510(k).
The record lists the applicant location as Baden-Wurttemberg, Germany. FDA found it substantially equivalent 276 calendar days after receipt (May 23, 2025 to February 23, 2026).
Clearance details
- Applicant
- Vita Zahnfabrik H. Rauter GmbH & Co. Kg.
- Product code
- Product code KLE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Baden-Wurttemberg, DE
Recent devices under product code KLE
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