The following data is part of a premarket notification filed by Vita Zanhnfabrik H. Rauter Gmbh Co. with the FDA for Vita Vionic Bond.
| Device ID | K191926 |
| 510k Number | K191926 |
| Device Name: | VITA VIONIC Bond |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | VITA Zanhnfabrik H. Rauter GmbH Co. Spitelgasse 3 Bad Sackingen, DE D-79713 |
| Contact | Bernd Walker |
| Correspondent | Lindsay Tilton VITA North America 22705 Savi Ranch Parkway, Sutie 100 Yorba Linda, CA 92887 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-18 |
| Decision Date | 2020-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J017AD9VBK0 | K191926 | 000 |
| J017AD9VBMDK0 | K191926 | 000 |
| J017AD9VBMDC0 | K191926 | 000 |