Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)
FDA 510(k) K241311 · Bernhard Förster GmbH
510(k) numberK241311
Submission
- Device name
- Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)
- Applicant
- Bernhard Förster GmbH
Pforzheim, DE - Received
- May 9, 2024
- Decision date
- August 2, 2024
- 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 |
| 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 |
| K232087 | Dental LT Comfort ResinMQC · Special | Formlabs Ohio, Inc. | 02/16/2024SE |
Questions and answers
When was Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) cleared by the FDA?
Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) (K241311) received a 510(k) decision of Substantially Equivalent on August 2, 2024, 85 days after the submission was received.
What is the product code of K241311?
The FDA product code is MQC – Mouthguard, Prescription, a Unclassified device.