Cleared Traditional

K062064 - RIVA BOND LC

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

K062064 · Southern Dental Industries, Inc. · Dental device
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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

FDA 510(k) Submission Details - K062064

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
Combination Product No
PCCP Authorized No
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.

EMA Device Classification - Class 2, Special Controls

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 433
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K062064.
MERON PLUS
K063554 · Voco GmbH · Jan 2007
ENA CEM
K062355 · Micerium S.P.A. · Dec 2006
RIVA LUTING PLUS
K062065 · Southern Dental Industries, Inc. · Nov 2006
UNICEM
K062292 · 3M Espe Dental Products · Oct 2006
NEXUS 3
K062519 · Kerr Corporation · Oct 2006
CLEARFIL ESTHETIC CEMENT & DC BOND
K062410 · Kuraray Medical, Inc. · Sep 2006