Hard Splint & Thermo-Adaptive Splint
FDA 510(k) clearance K241729 · decided 2025-03-18
Clearance details
- K-number
- K241729
- Device name
- Hard Splint & Thermo-Adaptive Splint
- Applicant
- Whip Mix Corporation
- Decision
- Substantially Equivalent
- Date received
- 2024-06-14
- Decision date
- 2025-03-18
- Days to decision
- 277 days
- Clearance type
- Traditional
- Product code
- MQC
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Louisville, KY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| UltraPrint-Dental Hard Splint UV (K253798) | Guangzhou Heygears IMC., Inc. | 2026-03-02 |
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| Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) (K241311) | Bernhard Förster GmbH | 2024-08-02 |
| Slow Wave DS8 (SWDS802) (K240463) | Slow Wave, Inc. | 2024-06-04 |
| RODIN 3D Resin SPLINT, Hard/Flex (K231793) | Belport Company, Inc., Gingi-Pak | 2024-03-26 |
| Dental LT Comfort Resin (K232087) | Formlabs Ohio, Inc. | 2024-02-16 |
| Myoaligner Appliance (K230548) | Myohealth Technologies, LLC | 2024-02-02 |
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Recalls involving this device
No recalls on record reference this clearance.