Cleared Traditional

K000140 - CLINI-DENT

K000140 is an FDA 510(k) clearance for CLINI-DENT, manufactured by The Precident Group. The device is a Class 1 Dental device with product code MAU cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K000140 · The Precident Group · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
106d
Days
Class 1
Risk

K000140 is an FDA 510(k) clearance for the CLINI-DENT. Classified as Eraser, Dental Stain (product code MAU), Class I - General Controls.

Submitted by The Precident Group (Durham, US). The FDA issued a Cleared decision on May 3, 2000 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6855 - 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 The Precident Group devices

FDA 510(k) Submission Details - K000140

510(k) Number K000140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2000
Decision Date May 03, 2000
Days to Decision 106 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

MAU Device Classification - Class 1, General Controls

Product Code MAU Eraser, Dental Stain
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6855
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.