Cleared Traditional

K012707 - ESTENIA

K012707 is the FDA 510(k) clearance for ESTENIA by Kuraray Medical, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K012707 · Kuraray Medical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
30d
Days
Class 2
Risk

K012707 is an FDA 510(k) clearance for the ESTENIA. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kuraray Medical, Inc. (New York, US). The FDA issued a Cleared decision on September 13, 2001 after a review of 30 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kuraray Medical, Inc. devices

Submission Details

510(k) Number K012707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2001
Decision Date September 13, 2001
Days to Decision 30 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
97d faster than avg
Panel avg: 127d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 515
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K012707.
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