510(k) K112508
K112508 is an FDA 510(k) premarket notification submitted by S-Denti Co., Ltd. for the device "I-ROOT 100". The FDA issued a decision of Substantially Equivalent on June 19, 2012. The device falls under product code LQY (Locator, Root Apex), a Class U device. S-Denti Co., Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 19, 2012
- Date Received
- August 30, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Locator, Root Apex
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type