The following data is part of a premarket notification filed by Neo Group Limited with the FDA for Neo Denta Zirconia.
| Device ID | K130198 |
| 510k Number | K130198 |
| Device Name: | NEO DENTA ZIRCONIA |
| Classification | Powder, Porcelain |
| Applicant | NEO GROUP LIMITED ROOM Q1D G/F, KAISER EST 3RD PHASE, 18 MAN LOK ST Hung Hom, Kowloon, HK Hk 852 |
| Contact | Mike Adams |
| Correspondent | Mike Adams NEO GROUP LIMITED ROOM Q1D G/F, KAISER EST 3RD PHASE, 18 MAN LOK ST Hung Hom, Kowloon, HK Hk 852 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-28 |
| Decision Date | 2013-10-21 |
| Summary: | summary |