The following data is part of a premarket notification filed by Coltene/whaledent Ag with the FDA for Temposil 2.
| Device ID | K083304 |
| 510k Number | K083304 |
| Device Name: | TEMPOSIL 2 |
| 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 | No |
| Date Received | 2008-11-10 |
| Decision Date | 2009-02-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J00667300 | K083304 | 000 |
| J00667290 | K083304 | 000 |
| J00667280 | K083304 | 000 |
| J00667270 | K083304 | 000 |
| J00636860 | K083304 | 000 |