Cleared Traditional

CENTRIX TRI-LAMINATE POST SYSTEM (K882125) - FDA 510(k) Clearance

Class I Dental device.

K882125 · Centrix, Inc. · Dental device
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Aug 1988
Decision
83d
Days
Class 1
Risk

K882125 is an FDA 510(k) clearance for the CENTRIX TRI-LAMINATE POST SYSTEM. Classified as Post, Root Canal (product code ELR), Class I - General Controls.

Submitted by Centrix, Inc. (Milford, US). The FDA issued a Cleared decision on August 11, 1988 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3810 - 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 Centrix, Inc. devices

Submission Details

510(k) Number K882125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1988
Decision Date August 11, 1988
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 127d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ELR Post, Root Canal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.