The following data is part of a premarket notification filed by Rizhao Huge Dental Industry Co., Ltd with the FDA for Elastic Impression Material.
| Device ID | K133071 |
| 510k Number | K133071 |
| Device Name: | ELASTIC IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | RIZHAO HUGE DENTAL INDUSTRY CO., LTD 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901 |
| Contact | Leon Lu |
| Correspondent | Leon Lu RIZHAO HUGE DENTAL INDUSTRY CO., LTD 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2014-05-28 |
| Summary: | summary |