The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Niveous Liquid Dam.
| Device ID | K021613 |
| 510k Number | K021613 |
| Device Name: | NIVEOUS LIQUID DAM |
| Classification | Dam, Rubber |
| Applicant | SHOFU DENTAL CORP. 1225 STONE DR. San Marcos, CA 92078 |
| Contact | Robert Noble |
| Correspondent | Robert Noble SHOFU DENTAL CORP. 1225 STONE DR. San Marcos, CA 92078 |
| Product Code | EIE |
| CFR Regulation Number | 872.6300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-16 |
| Decision Date | 2002-06-20 |
| Summary: | summary |