Cleared Abbreviated

K152373 - VITA VM LC Flow

K152373 is an FDA 510(k) clearance for VITA VM LC Flow, manufactured by Vita Zahnfabrik H.Rauter GmbH & Co.. The device is a Class 2 Dental device with product code EBF cleared through the Abbreviated 510(k) pathway after a 131-day FDA review.

K152373 · Vita Zahnfabrik H.Rauter GmbH & Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
131d
Days
Class 2
Risk

K152373 is an FDA 510(k) clearance for the VITA VM LC Flow. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Vita Zahnfabrik H.Rauter GmbH & Co. (Bad Sackingen, DE). The FDA issued a Cleared decision on December 30, 2015 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Vita Zahnfabrik H.Rauter GmbH & Co. devices

FDA 510(k) Submission Details - K152373

510(k) Number K152373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2015
Decision Date December 30, 2015
Days to Decision 131 days
Submission Type Abbreviated
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
3d slower than avg
Panel avg: 128d · This submission: 131d
Pathway characteristics
Standards-based clearance path.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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, Inc.
Nevine Erian

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.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 845
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