The following data is part of a premarket notification filed by Ams Co., Ltd with the FDA for Zr Dental Block.
| Device ID | K093571 |
| 510k Number | K093571 |
| Device Name: | ZR DENTAL BLOCK |
| Classification | Powder, Porcelain |
| Applicant | AMS CO., LTD #708 LE-MEILLEUR TOWN 837-19 GANGNAM-GU Seoul, KR 135-937 |
| Contact | Claude Yang |
| Correspondent | Claude Yang AMS CO., LTD #708 LE-MEILLEUR TOWN 837-19 GANGNAM-GU Seoul, KR 135-937 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-18 |
| Decision Date | 2010-03-12 |
| Summary: | summary |