The following data is part of a premarket notification filed by Coltene/whaledent Ag with the FDA for Retractofoam.
| Device ID | K050013 |
| 510k Number | K050013 |
| Device Name: | RETRACTOFOAM |
| Classification | Material, Impression |
| 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 | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-03 |
| Decision Date | 2005-02-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J00636750 | K050013 | 000 |