VeriSplint
FDA 510(k) K190107 · Whip Mix Corporation
510(k) numberK190107
Submission
- Device name
- VeriSplint
- Applicant
- Whip Mix Corporation
Louisville, KY, US - Received
- January 22, 2019
- Decision date
- July 10, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQC – Mouthguard, Prescription
- Device class
- Unclassified
Other 510(k)s with product code MQC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253798 | UltraPrint-Dental Hard Splint UVMQC · Traditional | Guangzhou Heygears IMC., Inc. | 03/02/2026SE |
| K250743 | Remvia NightGuardMQC · Traditional | Remvia | 12/05/2025SE |
| K251252 | NOBILCAM IMPAK DiscMQC · Traditional | Shandong Huge Dental Material Corporation | 08/01/2025SE |
| K241729 | Hard Splint & Thermo-Adaptive SplintMQC · Traditional | Whip Mix Corporation | 03/18/2025SE |
| K243516 | Remi Custom Night GuardMQC · Traditional | Grindguard, Inc. | 02/10/2025SE |
| K241369 | LIJIA Night GuardMQC · Traditional | Lijia, LLC | 08/22/2024SE |
| K231775 | GR Resin System MSIMQC · Traditional | Pro3Dure Medical | 08/08/2024SE |
| K241311 | Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B)…MQC · Traditional | Bernhard Förster GmbH | 08/02/2024SE |
| K240463 | Slow Wave DS8 (SWDS802)MQC · Traditional | Slow Wave, Inc. | 06/04/2024SE |
| K231793 | RODIN 3D Resin SPLINT, Hard/FlexMQC · Traditional | Belport Company, Inc., Gingi-Pak | 03/26/2024SE |
More from Belport Company, Inc., Gingi-Pak
| 510(k) | Device | Decision |
|---|---|---|
| K241729 | Hard Splint & Thermo-Adaptive SplintMQC · Traditional | 03/18/2025SE |
| K152443 | Vericore Gradient Temporary DiscEBG · Traditional | 05/11/2016SE |
| K142670 | Vericore Zirconia BlanksEIH · Special | 10/22/2014SE |
| K140877 | Vericore Zirconia BlanksEIH · Traditional | 09/03/2014SE |
| K140146 | Comfortsoft Soft Denture Liner SystemEBI · Traditional | 04/29/2014SE |
| K131760 | Whip Mix Preppies PlusEJR · Traditional | 03/26/2014SE |
| K092857 | Vericore Abutment in Titanium for Implant SystemsNHA · Traditional | 03/04/2010SE |
| K090976 | Vericore Abutment in Zirconia for Implant SystemsNHA · Traditional | 06/25/2009SE |
| K082299 | Vericore Implant AbutmentsNHA · Traditional | 11/20/2008SE |
Questions and answers
When was VeriSplint cleared by the FDA?
VeriSplint (K190107) received a 510(k) decision of Substantially Equivalent on July 10, 2019, 169 days after the submission was received.
What is the product code of K190107?
The FDA product code is MQC – Mouthguard, Prescription, a Unclassified device.