510(k) K143265
K143265 is an FDA 510(k) premarket notification submitted by Sun Medical Co., Ltd. for the device "Acrylic Block". The FDA issued a decision of Substantially Equivalent on Apr 14, 2015. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. Sun Medical Co., Ltd. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 14, 2015
- Date Received
- Nov 13, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Resin, Denture, Relining, Repairing, Rebasing
- Device Class
- Class II
- Regulation Number
- 872.3760
- Review Panel
- DE
- Submission Type
- 510(k)