Cleared Traditional

SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTRAORAL CAMERA, SPECTRA VU HDDI SV I INTRAORAL CAMERA, (K984332) - FDA 510(k) Clearance

Class I Dental device.

K984332 · International Technology Concepts · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
147d
Days
Class 1
Risk

K984332 is an FDA 510(k) clearance for the SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTRAORAL CAM.... Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by International Technology Concepts (Oakland, US). The FDA issued a Cleared decision on April 29, 1999 after a review of 147 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 International Technology Concepts devices

Submission Details

510(k) Number K984332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1998
Decision Date April 29, 1999
Days to Decision 147 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
20d slower than avg
Panel avg: 127d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 25
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K984332.
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MOBILE UNITS, I,II,III,IV
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