The following data is part of a premarket notification filed by Coltene/whaledent Ag with the FDA for Parapost Paracore Automix 5ml.
| Device ID | K052820 |
| 510k Number | K052820 |
| Device Name: | PARAPOST PARACORE AUTOMIX 5ML |
| Classification | Material, Tooth Shade, Resin |
| Applicant | COLTENE/WHALEDENT AG 1349 LEXINGTON AVENUE New York, NY 10128 |
| Contact | H. J. Vogelstein |
| Correspondent | H. J. Vogelstein COLTENE/WHALEDENT AG 1349 LEXINGTON AVENUE New York, NY 10128 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-04 |
| Decision Date | 2006-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J006600184790 | K052820 | 000 |
| J00615010 | K052820 | 000 |
| J00658530 | K052820 | 000 |
| J00658540 | K052820 | 000 |
| J00658830 | K052820 | 000 |
| J00658850 | K052820 | 000 |
| J0065890EM0 | K052820 | 000 |
| J006600113910 | K052820 | 000 |
| J00615020 | K052820 | 000 |
| J00615030 | K052820 | 000 |
| J00658840 | K052820 | 000 |
| J00658860 | K052820 | 000 |
| J00658870 | K052820 | 000 |
| J006600113920 | K052820 | 000 |
| J006600137530 | K052820 | 000 |
| J00615000 | K052820 | 000 |