The following data is part of a premarket notification filed by Rizhao Huge Dental Industry Co., Ltd with the FDA for Pmma Block.
| Device ID | K141421 |
| 510k Number | K141421 |
| Device Name: | PMMA BLOCK |
| Classification | Crown And Bridge, Temporary, Resin |
| 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 | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-30 |
| Decision Date | 2015-02-09 |
| Summary: | summary |