Cleared Traditional

K021083 - VERACAM

K021083 is an FDA 510(k) clearance for VERACAM, manufactured by Lumalite, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K021083 · Lumalite, Inc. · Dental device
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Aug 2002
Decision
149d
Days
Class 1
Risk

K021083 is an FDA 510(k) clearance for the VERACAM. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Lumalite, Inc. (Los Angeles, US). The FDA issued a Cleared decision on August 30, 2002 after a review of 149 days - within the typical 510(k) review window.

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: 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 Lumalite, Inc. devices

FDA 510(k) Submission Details - K021083

510(k) Number K021083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2002
Decision Date August 30, 2002
Days to Decision 149 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 127d · This submission: 149d
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 159
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