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510(k) K052271

RINSENDO by Air Techniques, Inc. — Product Code NYL

K052271 is an FDA 510(k) premarket notification submitted by Air Techniques, Inc. for the device "RINSENDO". The FDA issued a decision of Substantially Equivalent on May 26, 2006. The device falls under product code NYL (Handpiece, Air-Powered, Root Canal Irrigation), a Class I device regulated under 21 CFR 872.4200. Air Techniques, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2006
Date Received
August 19, 2005
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 Air Techniques, Inc.

  • K191623 — ScanX Touch/ScanX Duo Touch (August 21, 2019)
  • K190949 — ScanX Barrier Envelopes (July 26, 2019)
  • K101289 — SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-Q (August 3, 2010)
  • K090169 — SPECTRA FLUORESCENCE CARIES DETECTION DEVICE (August 18, 2009)
  • K050693 — ACCENT (May 26, 2005)
  • K042397 — SCANX 14 (October 5, 2004)
  • K042266 — ACCLAIM (August 31, 2004)
  • K031198 — SCANX 10 (June 20, 2003)
  • K024285 — A/T X-RAY 70 (April 16, 2003)
  • K013893 — SCANX (February 1, 2002)

Other clearances for product code NYL

  • K211721 — PS System (December 2, 2021)
  • 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)

FDA data resources