Slow Wave DS8 (SWDS802)
FDA 510(k) K240463 · Slow Wave, Inc.
510(k) numberK240463
Submission
- Device name
- Slow Wave DS8 (SWDS802)
- Applicant
- Slow Wave, Inc.
Spicewood, TX, US - Received
- February 16, 2024
- Decision date
- June 4, 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
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|---|---|---|---|
| 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 |
| 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 |
More from Formlabs Ohio, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K191320 | Slow Wave DS8LQZ · Traditional | 10/02/2020SE |
Questions and answers
When was Slow Wave DS8 (SWDS802) cleared by the FDA?
Slow Wave DS8 (SWDS802) (K240463) received a 510(k) decision of Substantially Equivalent on June 4, 2024, 109 days after the submission was received.
What is the product code of K240463?
The FDA product code is MQC – Mouthguard, Prescription, a Unclassified device.