Cleared Traditional

K063422 - BIOAGGREGATE (FDA 510(k) Clearance)

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

K063422 · Innovative Bioceramix, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Nov 2006
Decision
8d
Days
Class 2
Risk

K063422 is an FDA 510(k) clearance for the BIOAGGREGATE. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Innovative Bioceramix, Inc. (Vancouver, Bc, CA). The FDA issued a Cleared decision on November 21, 2006 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - 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 Innovative Bioceramix, Inc. devices

Submission Details

510(k) Number K063422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2006
Decision Date November 21, 2006
Days to Decision 8 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 127d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
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.

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