Cleared Traditional

CLINI-DENT (K000140) - FDA 510(k) Clearance

Class I Dental device.

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

Submission Details

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.

Device Classification

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.