Cleared Traditional

K162311 - Straumann PrefGel

K162311 · Institut Straumann AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
201d
Days
-
Risk

K162311 is an FDA 510(k) clearance for the Straumann PrefGel. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Institut Straumann AG (Basel, CH). The FDA issued a Cleared decision on March 7, 2017 after a review of 201 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 Institut Straumann AG devices

FDA 510(k) Submission Details - K162311

510(k) Number K162311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2016
Decision Date March 07, 2017
Days to Decision 201 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
74d slower than avg
Panel avg: 127d · This submission: 201d
Pathway characteristics
Predicate-based equivalence.

KJJ Device Classification - Class 0,

Product Code KJJ Cleanser, Root Canal
Device Class -

Regulatory Consultant

Straumann USA, LLC
JENNIFER M. JACKSON

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 - KJJ Cleanser, Root Canal

All 17
Devices cleared under the same product code (KJJ) and FDA review panel - the closest regulatory comparables to K162311.
Vista Rinse, Vista Rinse Plus
K193409 · Inter-Med/Vista Dental Products · Sep 2020
RC-Prime Root Canal Preparation Cream
K200330 · Pac-Dent, Inc. · Jul 2020
ChlorCid, ChlorCid V, ChlorCid Surf
K173163 · Ultradent Products, Inc. · Feb 2018
STRAUMANN PREFGEL
K063812 · Straumann USA · Jan 2007
CITRIC ACID 20% SOLUTION, MODEL 329
K063703 · Ultradent Products, Inc. · Dec 2006
FILE-EZE
K060335 · Ultradent Products, Inc. · Feb 2006