The following data is part of a premarket notification filed by Inter-med / Vista Dental Products with the FDA for Vista Clear.
| Device ID | K193389 |
| 510k Number | K193389 |
| Device Name: | Vista Clear |
| Classification | Cord, Retraction |
| Applicant | Inter-Med / Vista Dental Products 2200 South St. Ste. A Racine, WI 53404 |
| Contact | Alex Johnson |
| Correspondent | Alex Johnson Inter-Med / Vista Dental Products 2200 South St. Ste. A Racine, WI 53404 |
| Product Code | MVL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-06 |
| Decision Date | 2020-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20304040151383 | K193389 | 000 |
| 10304040151478 | K193389 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VISTA CLEAR 73625195 1441962 Dead/Cancelled |
MICROTEK MEDICAL, INC. 1986-10-14 |