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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 128d · 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 Consultant

California Department of Health Services
ALFREDO J QUATTRONE

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 - EJH Alloy, Metal, Base

All 151
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K031627.
VERASOFT ES
K033356 · Aalba Dent, Inc. · Dec 2003
DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST
K033045 · American Green Dent. Mfg, Inc. · Dec 2003
WIROBOND C
K032136 · Bego U.S.A. · Sep 2003
PD CASTA-H
K030632 · Mountain Medico, Inc. · May 2003
CERACAST-V
K030416 · Mountain Medico, Inc. · Apr 2003
SUPERBOND
K030161 · American Dent-All, Inc. · Mar 2003
K031627 · NANO-TICROWN
Download PDF FDA Summary Nano-Write Corp.