Cleared Traditional

K162662 - GingiDent Gingival Retraction Paste

K162662 · Pac-Dent International, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
389d
Days
-
Risk

K162662 is an FDA 510(k) clearance for the GingiDent Gingival Retraction Paste. Classified as Cord, Retraction (product code MVL).

Submitted by Pac-Dent International, Inc. (Brea, US). The FDA issued a Cleared decision on October 20, 2017 after a review of 389 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Pac-Dent International, Inc. devices

FDA 510(k) Submission Details - K162662

510(k) Number K162662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2016
Decision Date October 20, 2017
Days to Decision 389 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
262d slower than avg
Panel avg: 127d · This submission: 389d
Pathway characteristics
Predicate-based equivalence.

MVL Device Classification - Class 0,

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

All 28
Devices cleared under the same product code (MVL) and FDA review panel - the closest regulatory comparables to K162662.
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Smartcord, Smartcord X
K171577 · Eastdent Co., Ltd. · May 2018
Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials
K162948 · Kerr Corporation · Aug 2017
GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord
K162536 · Kerr Corporation · Feb 2017
GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord
K162164 · Kerr Corporation · Jan 2017