510(k) K213997
K213997 is an FDA 510(k) premarket notification submitted by Biotech Dental, Sas for the device "Kontact Dental Implant System". The FDA issued a decision of Substantially Equivalent on July 15, 2022. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Biotech Dental, Sas has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 2022
- Date Received
- December 21, 2021
- 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