The following data is part of a premarket notification filed by Ivoclar Usa, Inc. with the FDA for Sr-ivolen Tray Material.
| Device ID | K863421 |
| 510k Number | K863421 |
| Device Name: | SR-IVOLEN TRAY MATERIAL |
| Classification | Material, Impression Tray, Resin |
| Applicant | IVOCLAR USA, INC. BAUER, CHENG & ASSOCIATES 111 N. WABASH Chicago, IL 60602 |
| Contact | Bauer, Phd |
| Correspondent | Bauer, Phd IVOCLAR USA, INC. BAUER, CHENG & ASSOCIATES 111 N. WABASH Chicago, IL 60602 |
| Product Code | EBH |
| CFR Regulation Number | 872.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-04 |
| Decision Date | 1986-11-03 |