510(k) K002843
K002843 is an FDA 510(k) premarket notification submitted by Sultan Chemists, Inc. for the device "SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010". The FDA issued a decision of Substantially Equivalent on November 15, 2000. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Sultan Chemists, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 2000
- Date Received
- September 12, 2000
- 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