DUO TEMP
Cement, Dental
COLTENE/WHALEDENT AG
The following data is part of a premarket notification filed by Coltene/whaledent Ag with the FDA for Duo Temp.
Pre-market Notification Details
| Device ID | K072604 |
| 510k Number | K072604 |
| Device Name: | DUO TEMP |
| 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 | 2007-09-17 |
| Decision Date | 2007-11-16 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J00670900 | K072604 | 000 |
| J00658310 | K072604 | 000 |
| J00658300 | K072604 | 000 |
Trademark Results [DUO TEMP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DUO TEMP 72121216 0732890 Dead/Expired |
NATIONAL SILVER COMPANY 1961-06-01 |
 DUO TEMP 71687509 0631142 Dead/Expired |
SUNSHADE CORP. 1955-05-13 |
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