Cleared Traditional

SOLARO 33

K970045 · Metalor Dental USA Corp. · Dental
Mar 1997
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K970045 is an FDA 510(k) clearance for the SOLARO 33, a Alloy, Other Noble Metal (Class II — Special Controls, product code EJS), submitted by Metalor Dental USA Corp. (North Attleborough, US). The FDA issued a Cleared decision on March 5, 1997, 58 days after receiving the submission on January 6, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K970045 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 1997
Decision Date March 05, 1997
Days to Decision 58 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJS — Alloy, Other Noble Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3060