Cleared Traditional

NANO-TICROWN

K031627 · Nano-Write Corp. · Dental

Jun 2003

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K031627 is an FDA 510(k) clearance for the NANO-TICROWN, a Alloy, Metal, Base (Class II — Special Controls, product code EJH), submitted by Nano-Write Corp. (Livermore, US). The FDA issued a Cleared decision on June 11, 2003, 15 days after receiving the submission on May 27, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3710.

Submission Details

510(k) Number	K031627 FDA.gov
FDA Decision	Cleared 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