Cleared Traditional

PARAPOST FIBER WHITE (K000311) - FDA 510(k) Clearance

Class I Dental device.

K000311 · Coltene/Whaledent, Inc. · Dental device
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Mar 2000
Decision
42d
Days
Class 1
Risk

K000311 is an FDA 510(k) clearance for the PARAPOST FIBER WHITE. Classified as Post, Root Canal (product code ELR), Class I - General Controls.

Submitted by Coltene/Whaledent, Inc. (Mahwah, US). The FDA issued a Cleared decision on March 14, 2000 after a review of 42 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 Coltene/Whaledent, Inc. devices

Submission Details

510(k) Number K000311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2000
Decision Date March 14, 2000
Days to Decision 42 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
85d faster than avg
Panel avg: 127d · This submission: 42d
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.