VeriSplint
Mouthguard, Prescription
Whip Mix Corporation
The following data is part of a premarket notification filed by Whip Mix Corporation with the FDA for Verisplint.
Pre-market Notification Details
| Device ID | K190107 |
| 510k Number | K190107 |
| Device Name: | VeriSplint |
| Classification | Mouthguard, Prescription |
| Applicant | Whip Mix Corporation 361 Farmington Avenue Louisville, KY 40217 |
| Contact | John Waters |
| Correspondent | John Waters Whip Mix Corporation 361 Farmington Avenue Louisville, KY 40217 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-22 |
| Decision Date | 2019-07-10 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D040711471 | K190107 | 000 |
| D040711740 | K190107 | 000 |
Trademark Results [VeriSplint]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERISPLINT 88676863 not registered Live/Pending |
Whip-Mix Corporation 2019-11-01 |
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