The following data is part of a premarket notification filed by Zirkonzahn Srl with the FDA for Abro 1, Resiton Gingiva, Prime And Therapon Transpa.
| Device ID | K200676 |
| 510k Number | K200676 |
| Device Name: | ABRO 1, RESITON GINGIVA, PRIME And THERAPON TRANSPA |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | Zirkonzahn Srl Via An Der Ahr 7 Gais, IT 39030 |
| Contact | Julian Steger |
| Correspondent | Sandra Leitner Zirkonzahn Srl Via An Der Ahr 7 Gais, IT 39030 |
| Product Code | EBG |
| Subsequent Product Code | EBI |
| Subsequent Product Code | MQC |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-16 |
| Decision Date | 2020-07-08 |