The following data is part of a premarket notification filed by Coltene/whaledent Ag with the FDA for One Coat 7 Universal.
| Device ID | K152243 |
| 510k Number | K152243 |
| Device Name: | One Coat 7 Universal |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | Coltene/Whaledent AG Feldwiesentr.20 Altstatten, CH 9450 |
| Contact | Silke Wallaschek |
| Correspondent | Silke Wallaschek Coltene/Whaledent AG Feldwiesentr.20 Altstatten, CH 9450 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-10 |
| Decision Date | 2015-12-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J00670470 | K152243 | 000 |
| J006600195390 | K152243 | 000 |
| J006600195400 | K152243 | 000 |
| J006600195410 | K152243 | 000 |
| J006600201000 | K152243 | 000 |
| J00670540 | K152243 | 000 |
| J00670490 | K152243 | 000 |
| J006600196900 | K152243 | 000 |
| J006600196910 | K152243 | 000 |
| J006600195380 | K152243 | 000 |