Home / 510(k) Clearances / K162311

510(k) K162311

Straumann PrefGel by Institut Straumann AG — Product Code KJJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2017
Date Received
August 18, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleanser, Root Canal
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances by Institut Straumann AG

  • K252168 — Straumann® BLC Implants - Indication Widening (March 10, 2026)
  • K253315 — Straumann Variobase Abutments XC for Bridge/Bar (January 22, 2026)
  • K250294 — Straumann® RidgeFit Implants (August 12, 2025)
  • K243278 — Custom Abutments (February 21, 2025)
  • K243478 — Straumann InLab Validated Workflow (February 19, 2025)
  • K233252 — Straumann CARES Visual and Nova Dental CAD (December 26, 2024)
  • K241391 — Straumann® PURE Ceramic Implants (December 10, 2024)
  • K234049 — Straumann® BLC and TLC Implants - Line extension (March 20, 2024)
  • K230108 — Straumann® BLC and TLC Implants (September 14, 2023)
  • K223083 — Straumann SLActive labeling changes (June 22, 2023)

Other clearances for product code KJJ

  • K250279 — RC-SwiftPrep (July 2, 2025)
  • K241354 — Sealer Solvent (August 27, 2024)
  • K201785 — EPIEN Dental Cleanser (September 9, 2021)
  • K211813 — Triton (August 18, 2021)
  • K193357 — V-Mix (October 23, 2020)
  • K193409 — Vista Rinse, Vista Rinse Plus (September 9, 2020)
  • K200330 — RC-Prime Root Canal Preparation Cream (July 6, 2020)
  • K173163 — ChlorCid, ChlorCid V, ChlorCid Surf (February 9, 2018)
  • K160577 — PacEndo Chlorhexidine (July 25, 2016)
  • K153528 — PacEndo EDTA (February 1, 2016)