FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Vista FS, Vista FS Liquid
K Number: K190220
·
Decision Jun 10, 2019
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
35
Applicant Total
6
Review Days
125
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Basic Information
- Device Name
- Vista FS, Vista FS Liquid
- K Number
- K190220
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inter-Med/Vista Dental Products
- Date Received
- February 5, 2019
- Decision Date
- June 10, 2019
- Product Code
- MVL
- Advisory Committee
- Unknown
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| MVL | Cord, Retraction | FDA unclassified | Unknown |
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Other Clearances by Inter-Med/Vista Dental Products
| K Number | Device Name | ||
|---|---|---|---|
| K193357 | V-Mix | Oct 23, 2020 | Substantially Equivalent |
| K193409 | Vista Rinse, Vista Rinse Plus | Sep 9, 2020 | Substantially Equivalent |
| K193447 | Vista Dyes | Mar 11, 2020 | Substantially Equivalent |
| K193389 | Vista Clear | Mar 4, 2020 | Substantially Equivalent |
| K170101 | Valiant Curing Light | Jun 8, 2017 | Substantially Equivalent |