Cleared Traditional

ORACAM (K020957) - FDA 510(k) Clearance

Class I Dental device.

K020957 · Video Dental Concepts, Inc. · Dental device
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Jun 2002
Decision
80d
Days
Class 1
Risk

K020957 is an FDA 510(k) clearance for the ORACAM. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Video Dental Concepts, Inc. (Ormond Beach, US). The FDA issued a Cleared decision on June 13, 2002 after a review of 80 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 Video Dental Concepts, Inc. devices

Submission Details

510(k) Number K020957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2002
Decision Date June 13, 2002
Days to Decision 80 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
47d faster than avg
Panel avg: 127d · This submission: 80d
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 K020957.
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KSEA ENDOSCOPES FOR DENTAL PROCEDURES
K982658 · KARL STORZ Endoscopy-America, Inc. · Oct 1998
MOBILE UNITS, I,II,III,IV
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