The following data is part of a premarket notification filed by Noritake Co., Inc. with the FDA for Paste Opaque Ex-3.
| Device ID | K982766 |
| 510k Number | K982766 |
| Device Name: | PASTE OPAQUE EX-3 |
| Classification | Powder, Porcelain |
| Applicant | NORITAKE CO., INC. 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 -5339 |
| Contact | Marsha C Wertzberger |
| Correspondent | Marsha C Wertzberger NORITAKE CO., INC. 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 -5339 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-06 |
| Decision Date | 1998-10-30 |