The following data is part of a premarket notification filed by Kuraray Noritake Dental Inc. with the FDA for Katana Zirconia Block.
| Device ID | K170986 |
| 510k Number | K170986 |
| Device Name: | KATANA Zirconia Block |
| Classification | Powder, Porcelain |
| Applicant | Kuraray Noritake Dental Inc. Ote Center Bldg. 7F Chiyoda-ku, JP 100-0004 |
| Contact | Yasujiro Ohara |
| Correspondent | Yasujiro Ohara Kuraray Noritake Dental Inc. Ote Center Bldg. 7F 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 | 2017-04-03 |
| Decision Date | 2017-07-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKUR1256011KA0 | K170986 | 000 |
| EKUR1255841KA0 | K170986 | 000 |
| EKUR1255832KA0 | K170986 | 000 |
| EKUR1255821KA0 | K170986 | 000 |
| EKUR1255812KA0 | K170986 | 000 |
| EKUR1255801KA0 | K170986 | 000 |
| EKUR1255792KA0 | K170986 | 000 |
| EKUR1255781KA0 | K170986 | 000 |
| EKUR1255772KA0 | K170986 | 000 |
| EKUR1255761KA0 | K170986 | 000 |
| EKUR1255752KA0 | K170986 | 000 |
| EKUR1255741KA0 | K170986 | 000 |
| EKUR1255732KA0 | K170986 | 000 |
| EKUR1255721KA0 | K170986 | 000 |
| EKUR1255712KA0 | K170986 | 000 |
| EKUR1255852KA0 | K170986 | 000 |
| EKUR1255861KA0 | K170986 | 000 |
| EKUR1256000KA0 | K170986 | 000 |
| EKUR1255990KA0 | K170986 | 000 |
| EKUR1255980KA0 | K170986 | 000 |
| EKUR1255972KA0 | K170986 | 000 |
| EKUR1255961KA0 | K170986 | 000 |
| EKUR1255952KA0 | K170986 | 000 |
| EKUR1255941KA0 | K170986 | 000 |
| EKUR1255932KA0 | K170986 | 000 |
| EKUR1255921KA0 | K170986 | 000 |
| EKUR1255912KA0 | K170986 | 000 |
| EKUR1255901KA0 | K170986 | 000 |
| EKUR1255892KA0 | K170986 | 000 |
| EKUR1255881KA0 | K170986 | 000 |
| EKUR1255872KA0 | K170986 | 000 |
| EKUR1255701KA0 | K170986 | 000 |