FREEPRINT® splintmaster
FDA 510(k) K232448 · Detax GmbH
510(k) numberK232448
Submission
- Device name
- FREEPRINT® splintmaster
- Applicant
- Detax GmbH
Ettingen, DE - Received
- August 14, 2023
- Decision date
- October 12, 2023
- 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 |
|---|---|---|
| K252430 | Freeprint® denture flexEBI · Traditional | 10/30/2025SE |
| K222877 | FREEPRINT crownEBF · Traditional | 09/23/2022SE |
| K200461 | Freeprint dentureEBI · Traditional | 11/16/2020SE |
| K200273 | FREEPRINT tempEBG · Traditional | 10/27/2020SE |
| K162654 | mollosil plusEBI · Traditional | 03/13/2017SE |
| K100247 | Detax Implantlink SemiEMA · Traditional | 07/23/2010SE |
| K994012 | Tempofit, Model 02693EBG · Traditional | 02/16/2000SE |
Questions and answers
When was FREEPRINT® splintmaster cleared by the FDA?
FREEPRINT® splintmaster (K232448) received a 510(k) decision of Substantially Equivalent on October 12, 2023, 59 days after the submission was received.
What is the product code of K232448?
The FDA product code is MQC – Mouthguard, Prescription, a Unclassified device.