The following data is part of a premarket notification filed by Qinhuangdao Aidite High-technical Ceramics Co, Ltd with the FDA for Aidite Zirconia Dental Ceramics.
| Device ID | K111291 |
| 510k Number | K111291 |
| Device Name: | AIDITE ZIRCONIA DENTAL CERAMICS |
| Classification | Powder, Porcelain |
| Applicant | QINHUANGDAO AIDITE HIGH-TECHNICAL CERAMICS CO, LTD 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701 |
| Contact | Stuart R Goldman |
| Correspondent | Stuart R Goldman QINHUANGDAO AIDITE HIGH-TECHNICAL CERAMICS CO, LTD 611 WEST 5TH STREET THIRD FLOOR Austin, TX 78701 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-06 |
| Decision Date | 2011-07-20 |
| Summary: | summary |