Cleared Traditional

K031627 - NANO-TICROWN

K031627 is an FDA 510(k) clearance for NANO-TICROWN, manufactured by Nano-Write Corp.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K031627 · Nano-Write Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
15d
Days
Class 2
Risk

K031627 is an FDA 510(k) clearance for the NANO-TICROWN. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Nano-Write Corp. (Livermore, US). The FDA issued a Cleared decision on June 11, 2003 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3710 - 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 Nano-Write Corp. devices

FDA 510(k) Submission Details - K031627

510(k) Number K031627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2003
Decision Date June 11, 2003
Days to Decision 15 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 127d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

EJH Device Classification - Class 2, Special Controls

Product Code EJH Alloy, Metal, Base
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3710
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 - EJH Alloy, Metal, Base

All 100
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