The following data is part of a premarket notification filed by Coltene/whaledent Inc. with the FDA for Coltene President Jet Light/reg Body Hydrophilic.
| Device ID | K912485 |
| 510k Number | K912485 |
| Device Name: | COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC |
| Classification | Material, Impression |
| Applicant | COLTENE/WHALEDENT INC. 236 FIRTH AVE. New York, NY 10001 |
| Contact | Henry J Vogelstein |
| Correspondent | Henry J Vogelstein COLTENE/WHALEDENT INC. 236 FIRTH AVE. New York, NY 10001 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-04 |
| Decision Date | 1991-07-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640181478927 | K912485 | 000 |
| 07640370884287 | K912485 | 000 |
| 07640370884294 | K912485 | 000 |
| 07640181479368 | K912485 | 000 |
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| 07640370884331 | K912485 | 000 |
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| J00637510 | K912485 | 000 |
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| J006600201830 | K912485 | 000 |
| J006600218530 | K912485 | 000 |
| J0066003US0 | K912485 | 000 |
| J00661050 | K912485 | 000 |