Cleared Traditional

K211854 - VITA Akzent LC (FDA 510(k) Clearance)

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

K211854 · Vita Zahnfabrik GmbH H Rauter & CO · Dental device
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Nov 2021
Decision
159d
Days
Class 2
Risk

K211854 is an FDA 510(k) clearance for the VITA Akzent LC. Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by Vita Zahnfabrik GmbH H Rauter & CO (Bad Sackingen, DE). The FDA issued a Cleared decision on November 22, 2021 after a review of 159 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3310 - 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 K211854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2021
Decision Date November 22, 2021
Days to Decision 159 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 127d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBD Coating, Filling Material, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3310
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.

Regulatory Consultant

Vita North America
Lindsay Tilton

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.