FDA 510(k)
FDA class 2
Substantially Equivalent
🇱🇮 Liechtenstein
Helioseal F Plus
K Number: K190339
·
Decision Jul 29, 2019
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
31
Review Days
165
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Basic Information
- Device Name
- Helioseal F Plus
- K Number
- K190339
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ivoclar Vivadent, AG
- Date Received
- February 14, 2019
- Decision Date
- July 29, 2019
- Product Code
- EBC
- 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 |
|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | FDA class 2 | Dental |
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