Cleared Traditional

K062064 - RIVA BOND LC
(FDA 510(k) Clearance)

K062064 · Southern Dental Industries, Inc. · Dental
Nov 2006
Decision
112d
Days
Class 2
Risk

K062064 is an FDA 510(k) clearance for the RIVA BOND LC. This device is classified as 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 9, 2006, 112 days after receiving the submission on July 20, 2006.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K062064 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 2006
Decision Date November 09, 2006
Days to Decision 112 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