The following data is part of a premarket notification filed by Franz Biotech Inc. with the FDA for Franz Zirconia Dental Crown.
| Device ID | K203072 |
| 510k Number | K203072 |
| Device Name: | Franz Zirconia Dental Crown |
| Classification | Teeth, Porcelain |
| Applicant | Franz Biotech Inc. 5F.-3, No. 56, Ln. 258, Ruiguang Rd., Neihu Dist. Taipei City, TW 114 |
| Contact | Anita Chen |
| Correspondent | Anita Chen Franz Biotech Inc. 5F.-3, No. 56, Ln. 258, Ruiguang Rd., Neihu Dist. Taipei City, TW 114 |
| Product Code | ELL |
| CFR Regulation Number | 872.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-09 |
| Decision Date | 2022-01-19 |