FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇷 Brazil
BIO-C Sealer Ion+
K Number: K190537
·
Decision Dec 12, 2019
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
142
Applicant Total
5
Review Days
283
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BIO-C Sealer Ion+
- K Number
- K190537
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3820
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Angelus Industria DE Produtos Odontologicos S/A
- Date Received
- March 4, 2019
- Decision Date
- December 12, 2019
- Product Code
- KIF
- 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 |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KIF), ordered by most recent decision date.
Any-Paste
FDA 510(k)
FDA Class 2
·Dental
ZenSeal Pro
FDA 510(k)
FDA Class 2
·Dental
Root canal repair materials (nRoot BP)
FDA 510(k)
FDA Class 2
·Dental
Well-Root PT
FDA 510(k)
FDA Class 2
·Dental
One-Fil Putty Injectable
FDA 510(k)
FDA Class 2
·Dental
MTA vpt
FDA 510(k)
FDA Class 2
·Dental