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510(k) K160232

Disposable Barrier Sleeves and Covers by Dentsply International, Inc. — Product Code PEM

K160232 is an FDA 510(k) premarket notification submitted by Dentsply International, Inc. for the device "Disposable Barrier Sleeves and Covers". The FDA issued a decision of Substantially Equivalent on June 7, 2016. The device falls under product code PEM (Dental Barriers And Sleeves), a Class II device regulated under 21 CFR 878.4370. Dentsply International, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2016
Date Received
February 1, 2016
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 Dentsply International, Inc.

  • K160207 — ATLANTIS ISUS Implant Suprastructures (September 21, 2016)
  • K151439 — ATLANTIS ISUS (February 19, 2016)
  • K152247 — ATLANTIS Crown (January 29, 2016)
  • K151039 — ATLANTIS Abutment for NobelActive 3.0 (January 14, 2016)
  • K151619 — Prime&Bond Elect Universal Dental Adhesive (October 30, 2015)
  • K150535 — Cavitron Touch Ultrasonic Scaling System (June 16, 2015)
  • K142178 — PROROOT MTA WHITE, PROROOT MTA GRAY (February 26, 2015)
  • K131907 — RAYPEX 6 (January 31, 2014)
  • K131644 — ANKYLOS SYNCONE ABUTMENT 5(DEGREE) (January 22, 2014)
  • K132145 — MTM(R) CLEAR ALIGNER (October 11, 2013)

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)
  • K190949 — ScanX Barrier Envelopes (July 26, 2019)

FDA data resources