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510(k) K173163

ChlorCid, ChlorCid V, ChlorCid Surf by Ultradent Products, Inc. — Product Code KJJ

K173163 is an FDA 510(k) premarket notification submitted by Ultradent Products, Inc. for the device "ChlorCid, ChlorCid V, ChlorCid Surf". The FDA issued a decision of Substantially Equivalent on February 9, 2018. The device falls under product code KJJ (Cleanser, Root Canal), a Class U device. Ultradent Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2018
Date Received
September 29, 2017
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 Ultradent Products, Inc.

  • K262228 — Transcend Bulk Fill Flowable Composite (July 1, 2026)
  • K261404 — UltraEZ (April 30, 2026)
  • K240743 — Peak Universal Bond (March 20, 2024)
  • K240694 — FORMA Composite (Shade A3D) (March 15, 2024)
  • K221909 — J-Temp (July 1, 2022)
  • K220471 — VALO X, VALO X Accessory Lenses (February 22, 2022)
  • K211905 — UltraCal XS (October 13, 2021)
  • K211237 — UltraTemp Rez II (July 13, 2021)
  • K210550 — VALO Grand Corded and Accessory Lenses (March 1, 2021)
  • K190627 — VALO Grand Corded (April 29, 2019)

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)
  • K162311 — Straumann PrefGel (March 7, 2017)
  • K160577 — PacEndo Chlorhexidine (July 25, 2016)
  • K153528 — PacEndo EDTA (February 1, 2016)

FDA data resources