Cleared Traditional

K912720 - ENDO-CORE

K912720 is the FDA 510(k) clearance for ENDO-CORE by Metalor Dental USA Corp.. It is a Class 1 Dental device (product code ELR) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K912720 · Metalor Dental USA Corp. · Dental device
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Aug 1991
Decision
63d
Days
Class 1
Risk

K912720 is an FDA 510(k) clearance for the ENDO-CORE. Classified as Post, Root Canal (product code ELR), Class I - General Controls.

Submitted by Metalor Dental USA Corp. (Rockville Centre, US). The FDA issued a Cleared decision on August 20, 1991 after a review of 63 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 Metalor Dental USA Corp. devices

Submission Details

510(k) Number K912720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1991
Decision Date August 20, 1991
Days to Decision 63 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 127d · This submission: 63d
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.

Regulatory Peers - ELR Post, Root Canal

All 10
Devices cleared under the same product code (ELR) and FDA review panel - the closest regulatory comparables to K912720.
FIBREKOR POST SYSTEM
K983266 · Jeneric/Pentron, Inc. · Nov 1998
COSMOPOST
K972875 · Ivoclar North America, Inc. · Sep 1997
C-POST
K945370 · Bisco, Inc. · Mar 1995
FILPOST
K896928 · Ivoclar North America, Inc. · Mar 1990
AD POST
K884277 · J. Morita USA, Inc. · Dec 1988
CENTRIX TRI-LAMINATE POST SYSTEM
K882125 · Centrix, Inc. · Aug 1988