Cleared Special

K063812 - STRAUMANN PREFGEL (FDA 510(k) Clearance)

K063812 · Straumann USA · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
21d
Days
-
Risk

K063812 is an FDA 510(k) clearance for the STRAUMANN PREFGEL. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Straumann USA (Andover, US). The FDA issued a Cleared decision on January 12, 2007 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K063812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2006
Decision Date January 12, 2007
Days to Decision 21 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 127d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -