Cleared Traditional

K030516 - RIVA-SELF CURE

K030516 is the FDA 510(k) clearance for RIVA-SELF CURE by Southern Dental Industries, Inc.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K030516 · Southern Dental Industries, Inc. · Dental device
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Apr 2003
Decision
57d
Days
Class 2
Risk

K030516 is an FDA 510(k) clearance for the RIVA-SELF CURE. 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 April 17, 2003 after a review of 57 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Southern Dental Industries, Inc. devices

Submission Details

510(k) Number K030516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2003
Decision Date April 17, 2003
Days to Decision 57 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
70d faster than avg
Panel avg: 127d · This submission: 57d
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 K030516.
IONOFIL COLOR AC
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K030168 · Wieland Dental + Technik GmbH & Co. KG · Mar 2003
VITIQUE SYSTEM
K023649 · Dmg USA, Inc. · Jan 2003
TEMPORARY CEMENT-DC010002
K023727 · GC America, Inc. · Jan 2003