Cleared Traditional

K941452 - ULTRACAM II

K941452 is an FDA 510(k) clearance for ULTRACAM II, manufactured by Dental Vision Direct, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K941452 · Dental Vision Direct, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
78d
Days
Class 1
Risk

K941452 is an FDA 510(k) clearance for the ULTRACAM II. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Dental Vision Direct, Inc. (Los Angeles, US). The FDA issued a Cleared decision on June 10, 1994 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Dental Vision Direct, Inc. devices

FDA 510(k) Submission Details - K941452

510(k) Number K941452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1994
Decision Date June 10, 1994
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 127d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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 - EIA Unit, Operative Dental

All 189
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