Cleared Traditional

K162948 - Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials (FDA 510(k) Clearance)

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

Submission Details

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
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 127d · This submission: 291d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVL Cord, Retraction
Device Class -