Cleared Traditional

BALANCE ARTICULATOR (K811075) - FDA 510(k) Clearance

Class I Dental device.

K811075 · Almore Intl., Inc. · Dental device
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May 1981
Decision
23d
Days
Class 1
Risk

K811075 is an FDA 510(k) clearance for the BALANCE ARTICULATOR. Classified as Articulators (product code EJP), Class I - General Controls.

Submitted by Almore Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on May 13, 1981 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3150 - 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 Almore Intl., Inc. devices

Submission Details

510(k) Number K811075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1981
Decision Date May 13, 1981
Days to Decision 23 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 127d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EJP Articulators
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3150
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.