510(k) K102308
K102308 is an FDA 510(k) premarket notification submitted by Dentium Co., Ltd. for the device "SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS". The FDA issued a decision of Substantially Equivalent on November 22, 2010. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Dentium Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2010
- Date Received
- August 16, 2010
- Clearance Type
- Special
- 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