Cleared Traditional

PRECEDENT (K934405) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K934405 · Reliance Orthodontic Products, Inc. · Dental device
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Jan 1994
Decision
134d
Days
Class 2
Risk

K934405 is an FDA 510(k) clearance for the PRECEDENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Reliance Orthodontic Products, Inc. (Itasca, US). The FDA issued a Cleared decision on January 21, 1994 after a review of 134 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 Reliance Orthodontic Products, Inc. devices

Submission Details

510(k) Number K934405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1993
Decision Date January 21, 1994
Days to Decision 134 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
7d slower than avg
Panel avg: 127d · This submission: 134d
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 80
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K931229 · Dentsply Intl. · Jul 1993
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K923473 · Dentsply Intl. · Apr 1993