Cleared Traditional

K193434 - VITA LUMEX AC (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193434 · Vita Zahnfabrik GmbH H Rauter & CO · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2020
Decision
223d
Days
Class 2
Risk

K193434 is an FDA 510(k) clearance for the VITA LUMEX AC. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Vita Zahnfabrik GmbH H Rauter & CO (Bad Sackingen, DE). The FDA issued a Cleared decision on July 21, 2020 after a review of 223 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Vita Zahnfabrik GmbH H Rauter & CO devices

Submission Details

510(k) Number K193434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2019
Decision Date July 21, 2020
Days to Decision 223 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 127d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

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