The following data is part of a premarket notification filed by Kuraray Noritake Dental Inc. with the FDA for Esthetic Colorant.
| Device ID | K220369 |
| 510k Number | K220369 |
| Device Name: | Esthetic Colorant |
| Classification | Powder, Porcelain |
| Applicant | Kuraray Noritake Dental Inc. Tokiwabashi Tower, 2-6-4, Otemachi Chiyoda-ku, JP 100-0004 |
| Contact | Yasujiro Ohara |
| Correspondent | Yasujiro Ohara Kuraray Noritake Dental Inc. Tokiwabashi Tower, 2-6-4, Otemachi Chiyoda-ku, JP 100-0004 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-08 |
| Decision Date | 2022-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR2270019KA0 | K220369 | 000 |
| EKUR1270055KA0 | K220369 | 000 |
| EKUR1270065KA0 | K220369 | 000 |
| EKUR1270075KA0 | K220369 | 000 |
| EKUR1270085KA0 | K220369 | 000 |
| EKUR1270095KA0 | K220369 | 000 |
| EKUR1270105KA0 | K220369 | 000 |
| EKUR1270115KA0 | K220369 | 000 |
| EKUR1270125KA0 | K220369 | 000 |
| EKUR1270135KA0 | K220369 | 000 |
| EKUR1270145KA0 | K220369 | 000 |
| EKUR1270155KA0 | K220369 | 000 |
| EKUR1270165KA0 | K220369 | 000 |
| EKUR1270010KA0 | K220369 | 000 |