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510(k) K202831

The iMask Child's Face Mask by Pac-Dent, Inc. — Product Code OXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2021
Date Received
September 25, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pediatric/Child Facemask
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

A pediatric/child facemask is intended to be worn by the patient/child to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. The facemask is recommended for use in a healthcare setting with appropriate adult supervision.

Other clearances by Pac-Dent, Inc.

  • K202674 — Medidenta High Speed Handpieces (December 12, 2022)
  • K202920 — OptiComp (May 25, 2022)
  • 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)
  • K200330 — RC-Prime Root Canal Preparation Cream (July 6, 2020)

Other clearances for product code OXZ

  • K221753 — Kangbeier Child Surgical Mask (December 21, 2023)
  • K213427 — PRIMED Pediatric Facemask (November 22, 2022)
  • K210321 — Dukal Corporation Level 1 Pediatric Face Mask (March 29, 2022)
  • K201514 — Child Face Mask (October 10, 2021)
  • K190308 — Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), (September 17, 2019)
  • K160100 — Prestige Ameritech Pediatric/Child’s Face mask (October 7, 2016)
  • K113340 — KIMBERLY-CLARK CHILD'S FACEMASK (May 4, 2012)
  • K103150 — KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK (September 23, 2011)