510(k) K190537
K190537 is an FDA 510(k) premarket notification submitted by Angelus Industria DE Produtos Odontologicos S/A for the device "BIO-C Sealer Ion+". The FDA issued a decision of Substantially Equivalent on Dec 12, 2019. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820. Angelus Industria DE Produtos Odontologicos S/A has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 12, 2019
- Date Received
- Mar 4, 2019
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resin, Root Canal Filling
- Device Class
- Class II
- Regulation Number
- 872.3820
- Review Panel
- DE
- Submission Type
- 510(k)