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510(k) K211721

PS System by Inter-Med, Inc. — Product Code NYL

K211721 is an FDA 510(k) premarket notification submitted by Inter-Med, Inc. for the device "PS System". The FDA issued a decision of Substantially Equivalent on December 2, 2021. The device falls under product code NYL (Handpiece, Air-Powered, Root Canal Irrigation), a Class I device regulated under 21 CFR 872.4200. Inter-Med, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2021
Date Received
June 4, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Root Canal Irrigation
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

To clean the root canal prior to filling and used for root canal irrigation.

Other clearances by Inter-Med, Inc.

  • K253337 — REGEN Bioactive Cement (April 15, 2026)
  • K241489 — ReminGel (January 8, 2025)
  • K241457 — Vista BC Putty (August 28, 2024)
  • K241354 — Sealer Solvent (August 27, 2024)
  • K221811 — Vista BC Sealer (November 21, 2022)
  • K112250 — CHX=CHX PLUS (October 28, 2011)
  • K082470 — SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE (April 3, 2009)
  • K871291 — AM CATH ESWL STENT (April 30, 1987)
  • K864669 — AM CATH ESWL STENT (January 5, 1987)
  • K851922 — URETERAL STONE DISLODGER (August 2, 1985)

Other clearances for product code NYL

  • K162436 — EndoVac Pure (December 21, 2016)
  • K140685 — ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM (July 2, 2014)
  • K100606 — VATEA ENDONTIC IRRIGATION SYSTEM (May 28, 2010)
  • K052271 — RINSENDO (May 26, 2006)

FDA data resources