Cleared Traditional

K013690 - IDENT-A100 INTRAORAL VIDEO CAMERA

K013690 is an FDA 510(k) clearance for IDENT-A100 INTRAORAL VIDEO CAMERA, manufactured by Confident Technology, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K013690 · Confident Technology, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
84d
Days
Class 1
Risk

K013690 is an FDA 510(k) clearance for the IDENT-A100 INTRAORAL VIDEO CAMERA. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Confident Technology, Inc. (Chino, US). The FDA issued a Cleared decision on January 30, 2002 after a review of 84 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 - K013690

510(k) Number K013690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2001
Decision Date January 30, 2002
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 128d · This submission: 84d
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 282
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K013690.
BOYD DELIVERY UNIT
K020833 · Boyd Industries, Inc. · Aug 2002
ORACAM
K020957 · Video Dental Concepts, Inc. · Jun 2002
INTRAORAL CAMERA ME-15
K020206 · Dent Corp. Research & Development · Apr 2002
INTRAORAL LENS OPTION TO SPECTROSHADE
K012744 · Mht Optic Research AG · Jan 2002
SOPRO595 INTRA ORAL CAMERA
K012505 · Sopro · Oct 2001
GULLIVER AND CLASSE A
K012213 · American Dental Technologies, Inc. · Aug 2001
K013690 · IDENT-A100 INTRAORAL VIDEO CAMERA
Download PDF FDA Summary Confident Technology,…