The following data is part of a premarket notification filed by Zirkonzahn Srl with the FDA for Ice Zirkon Transluzent.
| Device ID | K132230 |
| 510k Number | K132230 |
| Device Name: | ICE ZIRKON TRANSLUZENT |
| Classification | Powder, Porcelain |
| Applicant | ZIRKONZAHN SRL 67 MAIN STREET Silver Creek, NY 14136 |
| Contact | Donna M Hartnett |
| Correspondent | Donna M Hartnett ZIRKONZAHN SRL 67 MAIN STREET Silver Creek, NY 14136 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-18 |
| Decision Date | 2014-11-05 |
| Summary: | summary |