510(k) K073043
K073043 is an FDA 510(k) premarket notification submitted by Sdi , Ltd. for the device "SET PP". The FDA issued a decision of Substantially Equivalent on December 14, 2007. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Sdi , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2007
- Date Received
- October 29, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Dental
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type