FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Plasdent Disposable Barrier Sleeves and Barrier Film
K Number: K201604
·
Decision Dec 23, 2020
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
14
Applicant Total
1
Review Days
191
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Basic Information
- Device Name
- Plasdent Disposable Barrier Sleeves and Barrier Film
- K Number
- K201604
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Plasdent Corporation
- Date Received
- June 15, 2020
- Decision Date
- December 23, 2020
- Product Code
- PEM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| PEM | Dental Barriers And Sleeves | FDA class 2 | General, Plastic Surgery |
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