Cleared Traditional

K112321 - CS 1200

K112321 is the FDA 510(k) clearance for CS 1200 by Carestream Health, Inc.. It is a Class 1 Dental device (product code EIA) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K112321 · Carestream Health, Inc. · Dental device
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Nov 2011
Decision
90d
Days
Class 1
Risk

K112321 is an FDA 510(k) clearance for the CS 1200. 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 November 10, 2011 after a review of 90 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 K112321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2011
Decision Date November 10, 2011
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 55
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