Cleared Traditional

K132953 - TIDISHEILD

K132953 is an FDA 510(k) clearance for TIDISHEILD, manufactured by Tidi Products,Llc. The device is a Class 2 Dental device with product code PEM cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K132953 · Tidi Products,Llc · Dental device
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Feb 2014
Decision
151d
Days
Class 2
Risk

K132953 is an FDA 510(k) clearance for the TIDISHEILD. Classified as Dental Barriers And Sleeves (product code PEM), Class II - Special Controls.

Submitted by Tidi Products,Llc (Neenah, US). The FDA issued a Cleared decision on February 18, 2014 after a review of 151 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 878.4370 - 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 Tidi Products,Llc devices

FDA 510(k) Submission Details - K132953

510(k) Number K132953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2013
Decision Date February 18, 2014
Days to Decision 151 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 127d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PEM Device Classification - Class 2, Special Controls

Product Code PEM Dental Barriers And Sleeves
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
Definition Intended To Serve As A Disposable Barrier For Dental Instruments To Reduce The Risk Of Cross Contamination Between Dental Patients.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.