Cleared Traditional

K191926 - VITA VIONIC Bond

K191926 is an FDA 510(k) clearance for VITA VIONIC Bond, manufactured by Vita Zanhnfabrik H. Rauter GmbH Co.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K191926 · Vita Zanhnfabrik H. Rauter GmbH Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2020
Decision
195d
Days
Class 2
Risk

K191926 is an FDA 510(k) clearance for the VITA VIONIC Bond. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Vita Zanhnfabrik H. Rauter GmbH Co. (Bad Sackingen, DE). The FDA issued a Cleared decision on January 29, 2020 after a review of 195 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 Zanhnfabrik H. Rauter GmbH Co. devices

FDA 510(k) Submission Details - K191926

510(k) Number K191926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2019
Decision Date January 29, 2020
Days to Decision 195 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
68d slower than avg
Panel avg: 127d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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.

Regulatory Peers - EBI Resin, Denture, Relining, Repairing, Rebasing

All 156
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K191926.
DIOnavi-Denture
K193623 · Dio Corporation · Oct 2020
BB Base 3D printing resin for denture base
K191591 · Enlighten Materials Co., Ltd. · Aug 2020
Flex Fit
K190790 · Dk Mungyo Corporation · Jul 2020
NextDent Denture 3D+
K191497 · Vertex-Dental B.V. · Nov 2019
Tokuyama Rebase III
K190940 · Tokuyama Dental Corporation · Oct 2019
Halley resin system
K191427 · Dentsply Sirona · Aug 2019