Cleared Traditional

K091186 - KODAK 1500 INTRAORAL CAMERA

K091186 is the FDA 510(k) clearance for KODAK 1500 INTRAORAL CAMERA by Carestream Health, Inc.. It is a Class 1 Dental device (product code EIA) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K091186 · Carestream Health, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
117d
Days
Class 1
Risk

K091186 is an FDA 510(k) clearance for the KODAK 1500 INTRAORAL CAMERA. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Carestream Health, Inc. (Atlanta, US). The FDA issued a Cleared decision on August 18, 2009 after a review of 117 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 Carestream Health, Inc. devices

Submission Details

510(k) Number K091186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2009
Decision Date August 18, 2009
Days to Decision 117 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
10d faster than avg
Panel avg: 127d · This submission: 117d
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 60
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K091186.
INTEGO Family and Accesories
K150909 · Sirona Dental Systems GmbH · Jul 2015
CS 1200
K112321 · Carestream Health, Inc. · Nov 2011
A-DEC 200 DENTAL SYSTEM
K102234 · A-Dec, Inc. · Nov 2010
A-DEC 334/335 DELIVERY SYSTEM
K082985 · A-Dec, Inc. · Dec 2008
A-DEC SELF-CONTAINED WATER SYSTEM
K051657 · A-Dec, Inc. · Aug 2005
SPACELINE EMCIA, MODEL CU580
K043496 · J. Morita USA, Inc. · Feb 2005