510(k) K134022
K134022 is an FDA 510(k) premarket notification submitted by Spident Co., Ltd. for the device "BASE IT". The FDA issued a decision of Substantially Equivalent on June 11, 2014. The device falls under product code EJK (Liner, Cavity, Calcium Hydroxide), a Class II device regulated under 21 CFR 872.3250. Spident Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 2014
- Date Received
- December 30, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Liner, Cavity, Calcium Hydroxide
- Device Class
- Class II
- Regulation Number
- 872.3250
- Review Panel
- DE
- Submission Type