Cleared Traditional

K162164 - GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord

K162164 · Kerr Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
163d
Days
-
Risk

K162164 is an FDA 510(k) clearance for the GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retrac.... Classified as Cord, Retraction (product code MVL).

Submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on January 13, 2017 after a review of 163 days - an extended review cycle.

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 Kerr Corporation devices

FDA 510(k) Submission Details - K162164

510(k) Number K162164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2016
Decision Date January 13, 2017
Days to Decision 163 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 127d · This submission: 163d
Pathway characteristics
Predicate-based equivalence.

MVL Device Classification - Class 0,

Product Code MVL Cord, Retraction
Device Class -

Regulatory Consultant

Sybron Dental Specialties
MOHAMMAD SAAD ANSARI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MVL Cord, Retraction

All 32
Devices cleared under the same product code (MVL) and FDA review panel - the closest regulatory comparables to K162164.
GingiDent Gingival Retraction Paste
K162662 · Pac-Dent International, Inc. · Oct 2017
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
Astringedent Clear
K152064 · Ultradent Products, Inc. · Sep 2015
EXPAZEN
K150423 · Produits Dentaires Pierre Rolland (Acteon Group) · Jul 2015
RETRACTION PASTE
K130580 · Dmg USA, Inc. · Feb 2014