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510(k) K190949

ScanX Barrier Envelopes by Air Techniques, Inc. — Product Code PEM

K190949 is an FDA 510(k) premarket notification submitted by Air Techniques, Inc. for the device "ScanX Barrier Envelopes". The FDA issued a decision of Substantially Equivalent on July 26, 2019. The device falls under product code PEM (Dental Barriers And Sleeves), a Class II device regulated under 21 CFR 878.4370. Air Techniques, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2019
Date Received
April 11, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dental Barriers And Sleeves
Device Class
Class II
Regulation Number
878.4370
Review Panel
DE
Submission Type

Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.

Other clearances by Air Techniques, Inc.

  • K191623 — ScanX Touch/ScanX Duo Touch (August 21, 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)
  • K052271 — RINSENDO (May 26, 2006)
  • 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 PEM

  • K250735 — Dental Barrier and Sleeves (June 10, 2025)
  • K250606 — Dental Barrier and Sleeves (May 29, 2025)
  • K242435 — Dental Barrier and Sleeves (October 18, 2024)
  • K233918 — Dental Barrier and Sleeves (May 9, 2024)
  • K220662 — Disposable Barrier Sleeves (May 11, 2022)
  • K211026 — Minitube Dentasleeve Protective Barrier Sleeves (August 3, 2021)
  • K201604 — Plasdent Disposable Barrier Sleeves and Barrier Film (December 23, 2020)
  • K191448 — Barrier Sleeves (October 8, 2019)
  • K190484 — BH Medical Dental Barrier Sleeves and Barrier Film (September 10, 2019)
  • K183263 — UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope (June 14, 2019)

FDA data resources