FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
The iMask Child's Face Mask
K Number: K202831
·
Decision Aug 26, 2021
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
8
Applicant Total
8
Review Days
335
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Basic Information
- Device Name
- The iMask Child's Face Mask
- K Number
- K202831
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pac-Dent, Inc.
- Date Received
- September 25, 2020
- Decision Date
- August 26, 2021
- Product Code
- OXZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OXZ | Pediatric/Child Facemask | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OXZ), ordered by most recent decision date.
Kangbeier Child Surgical Mask
FDA 510(k)
FDA Class 2
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PRIMED Pediatric Facemask
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Dukal Corporation Level 1 Pediatric Face Mask
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FDA 510(k)
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Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Prestige Ameritech Pediatric/Childs Face mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Pac-Dent, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K202674 | Medidenta High Speed Handpieces | Dec 12, 2022 | Substantially Equivalent |
| K202920 | OptiComp | May 25, 2022 | Substantially Equivalent |
| K210189 | Pac-Dent Denture Base Resin | Jul 28, 2021 | Substantially Equivalent |
| K210412 | Pac-Dent Ceramic Nanohybrid Resin | Jul 26, 2021 | Substantially Equivalent |
| K210186 | PacBond One | Jul 16, 2021 | Substantially Equivalent |
| K201182 | iMask Disposable Surgical Face Mask | Feb 19, 2021 | Substantially Equivalent |
| K200330 | RC-Prime Root Canal Preparation Cream | Jul 6, 2020 | Substantially Equivalent |