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

FDA 510(k) Submission Details - K132526

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

MVL Device Classification - Class 0,

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

All 27
Devices cleared under the same product code (MVL) and FDA review panel - the closest regulatory comparables to K132526.
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K113839 · Parkell, Inc. · Apr 2012
RE / STASIS (TM) GINGIVAL RETRACTION PASTE
K111348 · Centrix, Inc. · Jul 2011