Cleared Traditional

BIO-POST DENTAL POST SYSTEM (K974649) - FDA 510(k) Clearance

Class I Dental device.

K974649 · Advanced Aeromedical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
140d
Days
Class 1
Risk

K974649 is an FDA 510(k) clearance for the BIO-POST DENTAL POST SYSTEM. Classified as Post, Root Canal (product code ELR), Class I - General Controls.

Submitted by Advanced Aeromedical, Inc. (Great Neck,, US). The FDA issued a Cleared decision on May 1, 1998 after a review of 140 days - within the typical 510(k) review window.

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: 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 Advanced Aeromedical, Inc. devices

Submission Details

510(k) Number K974649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1997
Decision Date May 01, 1998
Days to Decision 140 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 127d · This submission: 140d
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.