Cleared Traditional

K940680 - VERSADOWEL POST SYSTEM

K940680 is an FDA 510(k) clearance for VERSADOWEL POST SYSTEM, manufactured by Dental Power, Inc.. The device is a Class 1 Dental device with product code ELR cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K940680 · Dental Power, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
33d
Days
Class 1
Risk

K940680 is an FDA 510(k) clearance for the VERSADOWEL POST SYSTEM. Classified as Post, Root Canal (product code ELR), Class I - General Controls.

Submitted by Dental Power, Inc. (Washington, D.C., US). The FDA issued a Cleared decision on March 15, 1994 after a review of 33 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 Dental Power, Inc. devices

FDA 510(k) Submission Details - K940680

510(k) Number K940680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1994
Decision Date March 15, 1994
Days to Decision 33 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
94d faster than avg
Panel avg: 127d · This submission: 33d
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 20
Devices cleared under the same product code (ELR) and FDA review panel - the closest regulatory comparables to K940680.
C-POST
K945370 · Bisco, Inc. · Mar 1995
THE STERN ROOT ANCHOR SYSTEM
K950213 · Sterngold/Implamed · Mar 1995
PARAPOST XT SYSTEM
K934192 · Coltene/Whaledent, Inc. · Jun 1994
ENDO-CORE
K912720 · Metalor Dental USA Corp. · Aug 1991
FILPOST
K896928 · Ivoclar North America, Inc. · Mar 1990
FLEXI-CAST CROWN CORE SYSTEM
K896693 · Essential Dental Systems, Inc. · Feb 1990