The following data is part of a premarket notification filed by Sultan Chemists, Inc. with the FDA for Sultan Sensitemp Resin Temporary Cement, Model 70010.
| Device ID | K002843 |
| 510k Number | K002843 |
| Device Name: | SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 |
| Classification | Cement, Dental |
| Applicant | SULTAN CHEMISTS, INC. 124 E. MISSOURI AVE. Kansas City, MO 64106 |
| Contact | Clark Smith |
| Correspondent | Clark Smith SULTAN CHEMISTS, INC. 124 E. MISSOURI AVE. Kansas City, MO 64106 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-12 |
| Decision Date | 2000-11-15 |