510(k) K181953
K181953 is an FDA 510(k) premarket notification submitted by Sds Swiss Dental Solutions AG for the device "SDS1.2 dental implant". The FDA issued a decision of Substantially Equivalent on Nov 20, 2019. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Sds Swiss Dental Solutions AG has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 20, 2019
- Date Received
- Jul 23, 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)