Cleared Traditional

K832919 - OPTI-BEAM IV

K832919 is an FDA 510(k) clearance for OPTI-BEAM IV, manufactured by Dentsply Intl.. The device is a Class 1 Dental device with product code EAZ cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K832919 · Dentsply Intl. · Dental device
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Optimized for regulatory review, auditing and printing
Mar 1984
Decision
190d
Days
Class 1
Risk

K832919 is an FDA 510(k) clearance for the OPTI-BEAM IV. Classified as Light, Operating, Dental (product code EAZ), Class I - General Controls.

Submitted by Dentsply Intl. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1984 after a review of 190 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4630 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentsply Intl. devices

FDA 510(k) Submission Details - K832919

510(k) Number K832919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1983
Decision Date March 02, 1984
Days to Decision 190 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
63d slower than avg
Panel avg: 127d · This submission: 190d
Pathway characteristics
Predicate-based equivalence.

EAZ Device Classification - Class 1, General Controls

Product Code EAZ Light, Operating, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4630
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.