510(k) K171185
K171185 is an FDA 510(k) premarket notification submitted by Biotem Co., Ltd. for the device "IR Type Implant System". The FDA issued a decision of Substantially Equivalent on December 1, 2017. 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 at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 1, 2017
- Date Received
- April 24, 2017
- 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