Cleared Traditional

K172952 - Figaro Crowns Anterior Crown Kit

K172952 is an FDA 510(k) clearance for Figaro Crowns Anterior Crown Kit, manufactured by Figaro Crowns, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K172952 · Figaro Crowns, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
280d
Days
Class 2
Risk

K172952 is an FDA 510(k) clearance for the Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Figaro Crowns, Inc. (Woodbury, US). The FDA issued a Cleared decision on July 3, 2018 after a review of 280 days - an extended review cycle.

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.

View all Figaro Crowns, Inc. devices

FDA 510(k) Submission Details - K172952

510(k) Number K172952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2017
Decision Date July 03, 2018
Days to Decision 280 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
153d slower than avg
Panel avg: 127d · This submission: 280d
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 Peers - EBF Material, Tooth Shade, Resin

All 684
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