The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for Multiple (addition Silicone Impression Material).
| Device ID | K041229 |
| 510k Number | K041229 |
| Device Name: | MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL) |
| Classification | Material, Impression |
| Applicant | COSMEDENT, INC. 401 NORTH MICHIGAN AVE. SUITE 2500 Chicago, IL 60611 |
| Contact | James L Sandrik |
| Correspondent | James L Sandrik COSMEDENT, INC. 401 NORTH MICHIGAN AVE. SUITE 2500 Chicago, IL 60611 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-10 |
| Decision Date | 2004-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D779703MP21 | K041229 | 000 |
| D779703LR21 | K041229 | 000 |
| D77970351P1 | K041229 | 000 |