Home / 510(k) Clearances / K200330

510(k) K200330

RC-Prime Root Canal Preparation Cream by Pac-Dent, Inc. — Product Code KJJ

K200330 is an FDA 510(k) premarket notification submitted by Pac-Dent, Inc. for the device "RC-Prime Root Canal Preparation Cream". The FDA issued a decision of Substantially Equivalent on July 6, 2020. The device falls under product code KJJ (Cleanser, Root Canal), a Class U device. Pac-Dent, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2020
Date Received
February 10, 2020
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 Pac-Dent, Inc.

  • K202674 — Medidenta High Speed Handpieces (December 12, 2022)
  • K202920 — OptiComp (May 25, 2022)
  • K202831 — The iMask Child's Face Mask (August 26, 2021)
  • K210189 — Pac-Dent Denture Base Resin (July 28, 2021)
  • K210412 — Pac-Dent Ceramic Nanohybrid Resin (July 26, 2021)
  • K210186 — PacBond One (July 16, 2021)
  • K201182 — iMask Disposable Surgical Face Mask (February 19, 2021)

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)
  • K173163 — ChlorCid, ChlorCid V, ChlorCid Surf (February 9, 2018)
  • K162311 — Straumann PrefGel (March 7, 2017)
  • K160577 — PacEndo Chlorhexidine (July 25, 2016)
  • K153528 — PacEndo EDTA (February 1, 2016)

FDA data resources