The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for D-sign I (r&d Project Dw263 #24).
| Device ID | K984451 |
| 510k Number | K984451 |
| Device Name: | D-SIGN I (R&D PROJECT DW263 #24) |
| Classification | Alloy, Other Noble Metal |
| Applicant | IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Peter P Mancuso |
| Correspondent | Peter P Mancuso IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | EJS |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-15 |
| Decision Date | 1999-01-19 |