The following data is part of a premarket notification filed by Ivoclar Usa, Inc. with the FDA for Ivocryl Heat Cure & Ivocryl Quick Denture Material.
| Device ID | K864709 |
| 510k Number | K864709 |
| Device Name: | IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| 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 | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-02 |
| Decision Date | 1987-02-10 |