The following data is part of a premarket notification filed by Denken-highdental Co., Ltd. with the FDA for Kdf Zirconia Disc.
| Device ID | K221429 |
| 510k Number | K221429 |
| Device Name: | KDF Zirconia Disc |
| Classification | Powder, Porcelain |
| Applicant | DENKEN-HIGHDENTAL Co., Ltd. 24-3 Kisshoin Ishiharakyomichi-cho, Minami-ku, JP 601-8356 |
| Contact | Daijiro Goto |
| Correspondent | Noriko Tanji DENKEN-HIGHDENTAL Co., Ltd. 24-3 Kisshoin Ishiharakyomichi-cho Minami-ku, JP 601-8356 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-16 |
| Decision Date | 2022-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560230233808 | K221429 | 000 |
| 04560230233921 | K221429 | 000 |
| 04560230233914 | K221429 | 000 |
| 04560230233907 | K221429 | 000 |
| 04560230234072 | K221429 | 000 |
| 04560230234065 | K221429 | 000 |
| 04560230234058 | K221429 | 000 |
| 04560230234041 | K221429 | 000 |
| 04560230234034 | K221429 | 000 |
| 04560230234027 | K221429 | 000 |
| 04560230234010 | K221429 | 000 |
| 04560230234003 | K221429 | 000 |
| 04560230233938 | K221429 | 000 |
| 04560230233945 | K221429 | 000 |
| 04560230233952 | K221429 | 000 |
| 04560230233792 | K221429 | 000 |
| 04560230233785 | K221429 | 000 |
| 04560230233778 | K221429 | 000 |
| 04560230233761 | K221429 | 000 |
| 04560230233754 | K221429 | 000 |
| 04560230233747 | K221429 | 000 |
| 04560230233730 | K221429 | 000 |
| 04560230233723 | K221429 | 000 |
| 04560230233983 | K221429 | 000 |
| 04560230233976 | K221429 | 000 |
| 04560230233969 | K221429 | 000 |
| 04560230233990 | K221429 | 000 |