510(k) K183024
K183024 is an FDA 510(k) premarket notification submitted by Implacil DE Bortoli Material Odontologico Ltda for the device "Implacil Implant System". The FDA issued a decision of Substantially Equivalent on Feb 13, 2020. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Implacil DE Bortoli Material Odontologico Ltda has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 13, 2020
- Date Received
- Nov 1, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type
- 510(k)