Cleared Traditional

K974649 - BIO-POST DENTAL POST SYSTEM

K974649 is an FDA 510(k) clearance for BIO-POST DENTAL POST SYSTEM, manufactured by Advanced Aeromedical, Inc.. The device is a Class 1 Dental device with product code ELR cleared through the Traditional 510(k) pathway after a 140-day FDA review.

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

FDA 510(k) Submission Details - K974649

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 127d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

ELR Device Classification - Class 1, General Controls

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.

Regulatory Peers - ELR Post, Root Canal

All 19
Devices cleared under the same product code (ELR) and FDA review panel - the closest regulatory comparables to K974649.
PARAPOST FIBER WHITE
K000311 · Coltene/Whaledent, Inc. · Mar 2000
FIBREKOR POST SYSTEM
K983266 · Jeneric/Pentron, Inc. · Nov 1998
KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC
K983161 · Sabre-K , Ltd. · Sep 1998
COSMOPOST
K972875 · Ivoclar North America, Inc. · Sep 1997
C-POST
K945370 · Bisco, Inc. · Mar 1995
THE STERN ROOT ANCHOR SYSTEM
K950213 · Sterngold/Implamed · Mar 1995