510(k) K180185
K180185 is an FDA 510(k) premarket notification submitted by Angelus Industria DE Produtos Odontologicos S/A for the device "BIO-C REPAIR". The FDA issued a decision of Substantially Equivalent on Aug 31, 2018. 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
- Aug 31, 2018
- Date Received
- Jan 23, 2018
- Clearance Type
- Traditional
- 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)