510(k) K190641
K190641 is an FDA 510(k) premarket notification submitted by Biotem Co., Ltd. for the device "AR_N SLA Type Implant System". The FDA issued a decision of Substantially Equivalent on Feb 21, 2020. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Biotem Co., Ltd. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 21, 2020
- Date Received
- Mar 13, 2019
- 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)