Cleared Traditional

K951019 - INTRAORAL VIDEO SCOPE AND WINDOW TUBE

K951019 is an FDA 510(k) clearance for INTRAORAL VIDEO SCOPE AND WINDOW TUBE, manufactured by Cuda Products Co.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K951019 · Cuda Products Co. · Dental device
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May 1995
Decision
64d
Days
Class 1
Risk

K951019 is an FDA 510(k) clearance for the INTRAORAL VIDEO SCOPE AND WINDOW TUBE. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on May 10, 1995 after a review of 64 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.

FDA 510(k) Submission Details - K951019

510(k) Number K951019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1995
Decision Date May 10, 1995
Days to Decision 64 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 128d · This submission: 64d
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 285
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K951019.
JACOBYSCOPE
K953912 · Perioview, Inc. · Nov 1995
STOMAVISION (STV)
K951074 · Trophy Radiologie · Sep 1995
SAFE-TIPS EZ
K951238 · Safe Wave Products, Inc. · May 1995
THE AQUA-AIR PROFESSIONAL FIELD UNIT(S)
K950175 · Aqua-Air Medical Devices, Inc. · Apr 1995
VACSTAR
K942698 · Air Techniques, Inc. · Mar 1995
VISTACAM
K943204 · Air Techniques, Inc. · Mar 1995
K951019 · INTRAORAL VIDEO SCOPE AND WINDOW TUBE
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