Cleared Traditional

K132526 - KNIT-PAK+

K132526 · Premier Dental Products Co. · Dental device
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Nov 2013
Decision
106d
Days
-
Risk

K132526 is an FDA 510(k) clearance for the KNIT-PAK+. Classified as Cord, Retraction (product code MVL).

Submitted by Premier Dental Products Co. (Plymouth Meeting, US). The FDA issued a Cleared decision on November 26, 2013 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. 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 Premier Dental Products Co. devices

Submission Details

510(k) Number K132526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2013
Decision Date November 26, 2013
Days to Decision 106 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
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

All 14
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