Cleared Traditional

K062064 - RIVA BOND LC

K062064 is the FDA 510(k) clearance for RIVA BOND LC by Southern Dental Industries, Inc.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K062064 · Southern Dental Industries, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
112d
Days
Class 2
Risk

K062064 is an FDA 510(k) clearance for the RIVA BOND LC. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Southern Dental Industries, Inc. (Bensenville, US). The FDA issued a Cleared decision on November 9, 2006 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Southern Dental Industries, Inc. devices

Submission Details

510(k) Number K062064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 127d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 Peers - EMA Cement, Dental

All 300
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K062064.
GVC-100
K070840 · GC America, Inc. · May 2007
GC FUJI IX GP EXTRA
K070319 · GC America, Inc. · Feb 2007
MERON PLUS
K063554 · Voco GmbH · Jan 2007
NEXUS 3
K062519 · Kerr Corporation · Oct 2006
CLEARFIL ESTHETIC CEMENT & DC BOND
K062410 · Kuraray Medical, Inc. · Sep 2006
MULTILINK SPRINT
K061781 · Ivoclar Vivadent, Inc. · Sep 2006