FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Vista Dyes
K Number: K193447
·
Decision Mar 11, 2020
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
16
Applicant Total
6
Review Days
89
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Basic Information
- Device Name
- Vista Dyes
- K Number
- K193447
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1740
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inter-Med/Vista Dental Products
- Date Received
- December 13, 2019
- Decision Date
- March 11, 2020
- Product Code
- LFC
- Advisory Committee
- Dental
- 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 |
|---|---|---|---|
| LFC | Device, Caries Detection | FDA class 2 | Dental |
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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 |
| K193389 | Vista Clear | Mar 4, 2020 | Substantially Equivalent |
| K190220 | Vista FS, Vista FS Liquid | Jun 10, 2019 | Substantially Equivalent |
| K170101 | Valiant Curing Light | Jun 8, 2017 | Substantially Equivalent |