The following data is part of a premarket notification filed by Rizhao Huge Dental Industry Co., Ltd with the FDA for All-ceramic Zirconia Block.
| Device ID | K141162 |
| 510k Number | K141162 |
| Device Name: | ALL-CERAMIC ZIRCONIA BLOCK |
| Classification | Powder, Porcelain |
| Applicant | RIZHAO HUGE DENTAL INDUSTRY CO., LTD ROOM 302, NO. 21 BLDG, KAIYU GARDEN, XISHAN SOUTH ROAD Wenzhou, Zhejiang, CN 325000 |
| Contact | Helen Nan |
| Correspondent | Helen Nan RIZHAO HUGE DENTAL INDUSTRY CO., LTD ROOM 302, NO. 21 BLDG, KAIYU GARDEN, XISHAN SOUTH ROAD Wenzhou, Zhejiang, CN 325000 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-05 |
| Decision Date | 2014-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970402670306 | K141162 | 000 |
| 06970402670238 | K141162 | 000 |
| 06970402670221 | K141162 | 000 |
| 06970402670207 | K141162 | 000 |
| 06970402670191 | K141162 | 000 |
| 06970402670184 | K141162 | 000 |