510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162311Substantially Equivalent

Straumann PrefGel

Straumann USA, LLC, Basel, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162311 is the FDA 510(k) clearance record for Straumann PrefGel, cleared for Institut Straumann AG on under FDA product code KJJ (Cleanser, Root Canal). FDA records list 176 510(k) clearances for Straumann USA, LLC, from to . As of , FDA records show no recalls naming K162311.

Clearance record

Decision date
Received
(201 days to decision)
Product code
KJJ Cleanser, Root Canal
Device class
Unclassified
Review panel
Unknown
Applicant
Institut Straumann AG Peter Merian Weg 12, Basel, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KJJ

Trailing 12 months

FDA records hold no clearances under product code KJJ in the trailing twelve months.

FDA records show no clearances under product code KJJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KJJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260