The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for X-l (dw228-14a) And X-lx (dw228-24a).
| Device ID | K913070 |
| 510k Number | K913070 |
| Device Name: | X-L (DW228-14A) AND X-LX (DW228-24A) |
| Classification | Alloy, Other Noble Metal |
| Applicant | IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Lloyd V Ziemendorf |
| Correspondent | Lloyd V Ziemendorf 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 | 1991-07-11 |
| Decision Date | 1991-09-13 |