The following data is part of a premarket notification filed by Vatech Acucera, Inc. with the FDA for Perfit Fs Dental Zirconia Fully Sintered Block.
| Device ID | K222686 |
| 510k Number | K222686 |
| Device Name: | Perfit FS Dental Zirconia Fully Sintered Block |
| Classification | Powder, Porcelain |
| Applicant | Vatech Acucera, Inc. 2544, Nambuk-daero, Idong-eup, Cheoin-gu Yongin-si, KR 17138 |
| Contact | Kwon Kyung Wook |
| Correspondent | Kwon Kyung Wook Vatech Acucera, Inc. 2544, Nambuk-daero, Idong-eup, Cheoin-gu Yongin-si, KR 17138 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-06 |
| Decision Date | 2022-10-06 |