Cleared Traditional

RIVA LUTING PLUS

K062065 · Southern Dental Industries, Inc. · Dental
Nov 2006
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K062065 is an FDA 510(k) clearance for the RIVA LUTING PLUS, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Southern Dental Industries, Inc. (Bensenville, US). The FDA issued a Cleared decision on November 15, 2006, 118 days after receiving the submission on July 20, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K062065 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 2006
Decision Date November 15, 2006
Days to Decision 118 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275