Cleared Traditional

K143694 - Rhondium One-Visit-Crown(OVC)

K143694 is an FDA 510(k) clearance for Rhondium One-Visit-Crown(OVC), manufactured by Rhondium, Ltd.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K143694 · Rhondium, Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
142d
Days
Class 2
Risk

K143694 is an FDA 510(k) clearance for the Rhondium One-Visit-Crown(OVC). Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Rhondium, Ltd. (Katikati, NZ). The FDA issued a Cleared decision on May 15, 2015 after a review of 142 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 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.

FDA 510(k) Submission Details - K143694

510(k) Number K143694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2014
Decision Date May 15, 2015
Days to Decision 142 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
14d slower than avg
Panel avg: 128d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

PaxMed International, LLC
Kevin A Thomas

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 863
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K143694.
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