Cleared Traditional

Straumann PrefGel (K162311) - FDA 510(k) Clearance

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

Submission Details

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.

Device Classification

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 15
Devices cleared under the same product code (KJJ) and FDA review panel - the closest regulatory comparables to K162311.
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RC-Prime Root Canal Preparation Cream
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FILE-EZE
K060335 · Ultradent Products, Inc. · Feb 2006
ENDOPURE ROOT CANAL CLEANSER
K032361 · Dentsply Intl. · Jan 2004