The following data is part of a premarket notification filed by Coltene Ag with the FDA for Cool Temp Natural.
| Device ID | K041098 |
| 510k Number | K041098 |
| Device Name: | COOL TEMP NATURAL |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | COLTENE AG 1349 LEXINGTON AVE. New York, NY 10128 |
| Contact | H.j. Vogelstein |
| Correspondent | H.j. Vogelstein COLTENE AG 1349 LEXINGTON AVE. New York, NY 10128 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-27 |
| Decision Date | 2004-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J00658250 | K041098 | 000 |
| J00658240 | K041098 | 000 |
| J00658200 | K041098 | 000 |
| J00658150 | K041098 | 000 |
| J00658100 | K041098 | 000 |
| J00658050 | K041098 | 000 |
| J00658000 | K041098 | 000 |