The following data is part of a premarket notification filed by Zirkonzahn Gmbh with the FDA for Zirkonzahn Ice.
| Device ID | K061851 |
| 510k Number | K061851 |
| Device Name: | ZIRKONZAHN ICE |
| Classification | Powder, Porcelain |
| Applicant | ZIRKONZAHN GMBH 67 MAIN STREET Silver Creek, NY 14136 |
| Contact | Donna M Hartnett |
| Correspondent | Donna M Hartnett ZIRKONZAHN GMBH 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 | 2006-06-30 |
| Decision Date | 2006-09-29 |