Cleared Traditional

K162948 - Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials

K162948 · Kerr Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
291d
Days
-
Risk

K162948 is an FDA 510(k) clearance for the Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Re.... Classified as Cord, Retraction (product code MVL).

Submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on August 8, 2017 after a review of 291 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 - K162948

510(k) Number K162948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2016
Decision Date August 08, 2017
Days to Decision 291 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
164d slower than avg
Panel avg: 127d · This submission: 291d
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 K162948.
Vista FS, Vista FS Liquid
K190220 · Inter-Med/Vista Dental Products · Jun 2019
Smartcord, Smartcord X
K171577 · Eastdent Co., Ltd. · May 2018
GingiDent Gingival Retraction Paste
K162662 · Pac-Dent International, Inc. · Oct 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
Astringedent Clear
K152064 · Ultradent Products, Inc. · Sep 2015