Cleared Traditional

K884277 - AD POST

K884277 is an FDA 510(k) clearance for AD POST, manufactured by J. Morita USA, Inc.. The device is a Class 1 Dental device with product code ELR cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K884277 · J. Morita USA, Inc. · Dental device
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Dec 1988
Decision
71d
Days
Class 1
Risk

K884277 is an FDA 510(k) clearance for the AD POST. Classified as Post, Root Canal (product code ELR), Class I - General Controls.

Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on December 22, 1988 after a review of 71 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 J. Morita USA, Inc. devices

FDA 510(k) Submission Details - K884277

510(k) Number K884277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1988
Decision Date December 22, 1988
Days to Decision 71 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 127d · This submission: 71d
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 K884277.
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
CENTRIX TRI-LAMINATE POST SYSTEM
K882125 · Centrix, Inc. · Aug 1988
DEN-MAT SECURE ANTI-ROTATIONAL POST-CORE SYSTEM
K870130 · Den-Mat Corp. · Feb 1987
ROOT CANAL POST
K802515 · Unitek Corp. · Nov 1980