Cleared Traditional

K912720 - ENDO-CORE

K912720 is an FDA 510(k) clearance for ENDO-CORE, manufactured by Metalor Dental USA Corp.. The device is a Class 1 Dental device with 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

FDA 510(k) Submission Details - K912720

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.

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 K912720.
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
FILPOST
K896928 · Ivoclar North America, Inc. · Mar 1990
FLEXI-CAST CROWN CORE SYSTEM
K896693 · Essential Dental Systems, Inc. · Feb 1990
AD POST
K884277 · J. Morita USA, Inc. · Dec 1988