The following data is part of a premarket notification filed by Coltene/whaledent Ag with the FDA for Paracem Universal Dc.
| Device ID | K053040 |
| 510k Number | K053040 |
| Device Name: | PARACEM UNIVERSAL DC |
| Classification | Cement, Dental |
| Applicant | COLTENE/WHALEDENT AG 1349 LEXINGTON AVENUE New York, NY 10128 |
| Contact | Henry J Vogelstein |
| Correspondent | Henry J Vogelstein COLTENE/WHALEDENT AG 1349 LEXINGTON AVENUE New York, NY 10128 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-10-27 |
| Decision Date | 2005-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J00674940 | K053040 | 000 |
| J00674930 | K053040 | 000 |
| J00674860 | K053040 | 000 |